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# Global Regulatory Solutions and Services Company

## Sitemaps
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## Posts
- [Everything a Regulatory Intelligence Tool Can Do for Life Sciences Companies](https://www.freyrregintel.com/everything-a-regulatory-intelligence-tool-can-do-for-life-sciences-companies/): A regulatory intelligence tool for life sciences earlier used to mean one thing: finding regulatory updates faster. That was useful, but limited. Regulatory teams today need more than alerts. They need context, relevance, traceability, and a practical way to decide what a new requirement means for products, markets, labels, submissions, quality processes, and so on.
- [What Are the Most Important Pharmaceutical Industry Regulations in 2026](https://www.freyrregintel.com/what-are-the-most-important-pharmaceutical-industry-regulations-in-2026/): Regulatory changes in 2026 are not limited to one market, one product category, or one function. From EU pharmaceutical legislation and FDA guidance shifts to MoCRA enforcement and medical device cybersecurity expectations, organizations need more than awareness. They need clear interpretation, practical impact assessment, and expert-led regulatory action plans to keep pace with changing Pharmaceutical Industry Regulations.
- [How Is Artificial Intelligence Transforming Regulatory Affairs?](https://www.freyrregintel.com/how-is-artificial-intelligence-transforming-regulatory-affairs/): The more interesting development is what generative AI in regulatory affairs is doing with document authoring itself. Tools trained on CTD structures and historical submission data can now produce working drafts of nonclinical summaries, clinical overviews, and rationale sections. Research has found that LLM-generated clinical document summaries can match physician-written versions in completeness and accuracy while being produced up to 28 times faster.
- [How Regulatory Intelligence Consulting Supports Compliance Strategy](https://www.freyrregintel.com/how-regulatory-intelligence-consulting-supports-compliance-strategy/): In the world of pharmaceuticals, medical devices and cosmetics, regulatory intelligence consulting provides companies with evolving legal and marketing frameworks in a given region or nation state. This data is then used by the private sector entity to attend to the needs of consumers in that area, whilst being in lock step with its laws.
- [How to Manage Global Regulatory Changes in Pharma](https://www.freyrregintel.com/how-to-manage-global-regulatory-changes-in-pharma/): Regulatory change is constant. That is the operating reality for every pharmaceutical company with a global footprint. Between shifting ICH guidelines, region-specific submissions requirements, post-Brexit MHRA divergence from EMA, and the U.S. FDA's rolling guidance updates, the volume of regulatory signals that a mid-to-large pharma organization must track, interpret, and act on has grown substantially. Global regulatory change management has become a core strategic capability and the companies treating it as such are pulling ahead.
- [How Regulatory Intelligence Software Helps Track Global Regulations](https://www.freyrregintel.com/how-regulatory-intelligence-software-helps-track-global-regulations/): Most companies think the global tracking problem is a volume problem. It's actually an interpretation problem, and that's a much harder one to solve with technology alone. The EMA and FDA may both have issued guidance on the same therapeutic class last quarter, but the submission formats, the evidentiary standards, and the post-approval variation notification pathways differ in ways that are consequential for your operations. Global regulatory tracking is an analytical function that requires market-specific context layered on top of the raw regulatory content.
- [Regulatory Intelligence for Medical Devices: Why It Matters and How It Works](https://www.freyrregintel.com/regulatory-intelligence-for-medical-devices-why-it-matters-and-how-it-works/): This is what the absence of Regulatory Intelligence for medical devices actually looks like in practice. Expensive and entirely avoidable.
- [Regulatory Intelligence vs. Manual Regulatory Tracking: Which Works Best?](https://www.freyrregintel.com/regulatory-intelligence-vs-manual-regulatory-tracking-which-works-best/): The debate around Regulatory Intelligence vs manual tracking has been simmering for years. At this point, for any company operating across more than two or three markets, it has moved well past debate – especially after AI became more than a buzzword.
- [The Evolving Landscape of Japanese Regulatory Affairs](https://www.freyrregintel.com/the-evolving-landscape-of-japanese-regulatory-affairs/): When it comes to the currently re-shaping situation in Japanese Regulatory Affairs, companies need to fully understand the transformation and how it will affect their bottomline. This involves both marketing and legal facets. From linguistic requirements to navigating the new bureaucracy, as a drug company, your job is to stay up to date. The system has been streamlined and expedited which is good news, but the know-how with regards to the difference between the Japan drug approval process, is difficult to master.
- [Key Features to Look for in AI Regulatory Intelligence Chatbots](https://www.freyrregintel.com/key-features-to-look-for-in-ai-regulatory-intelligence-chatbots/): When you step back, the features of AI regulatory intelligence chatbots that truly matter converge into three capabilities:
- [AI Chatbots for Faster Regulatory Intelligence Research and Analysis](https://www.freyrregintel.com/ai-chatbots-for-faster-regulatory-intelligence-research-and-analysis/): Regulatory affairs professionals have long operated in a world of impossible demands: monitor hundreds of global agencies simultaneously, interpret evolving guidance in real time, and maintain submission-ready documentation, all without missing a beat. AI Chatbots for Regulatory Intelligence are fundamentally rewriting the rules of that game. They hint towards a structural shift in how life sciences organizations access, interpret, and act on regulatory information and the organizations that recognize this early will carry a formidable competitive advantage.
- [5 Business Benefits of AI Regulatory Intelligence Chatbots](https://www.freyrregintel.com/5-business-benefits-of-ai-regulatory-intelligence-chatbots/): The bigger story, though, is how these tools change the way regulatory teams operate. Below are five business benefits of AI regulatory intelligence chatbots that are quietly reshaping regulatory affairs.
- [AI in Compliance: How AI-Driven Regulatory Intelligence Enables Smarter, Human-Led Decisions](https://www.freyrregintel.com/ai-in-compliance-how-ai-driven-regulatory-intelligence-enables-smarter-human-led-decisions/): AI in Compliance has moved from experimentation to expectation. Across pharma, biotech, and medical devices, algorithms now scan thousands of regulatory sources daily, flag changes in near real time, and surface patterns no human team could reasonably detect alone. And yet, for all this computational muscle, human-led compliance in pharma has never been more critical.
- [How Regulatory Intelligence Supports Sustainability and Compliance Goals in Life Sciences](https://www.freyrregintel.com/how-regulatory-intelligence-supports-sustainability-and-compliance-goals-in-life-sciences/): Life sciences industry is this mix of breakthrough innovation and stringent rules that keep changing. From drugs and biologics to devices and biotech, compliance is what keeps business afloat, ethics solid, and the world trusting what companies like you build. That's exactly why regulatory intelligence for life sciences compliance has become the backbone of how forward-thinking organizations operate.
- [How Life Sciences Companies Can Master Real-Time Regulatory Monitoring Across Global Markets](https://www.freyrregintel.com/how-life-sciences-companies-can-master-real-time-regulatory-monitoring-across-global-markets/): See how global real-time monitoring in regulatory intelligence affairs is augmented through the effective use of AI-driven methodologies
- [Key Takeaways: Regulatory Intelligence Conference Europe 2025](https://www.freyrregintel.com/top-takeaways-from-the-regulatory-intelligence-conference-europe-2025-what-regulatory-leaders-need-to-know/): This year, RAPS and TOPRA jointly hosted the Regulatory Intelligence Conference Europe 2025, bringing together industry leaders for a deep, targeted exploration of the most urgent RI themes. The event delivered actionable insights, strategic discussions, and meaningful connections.
- [Navigating the AI Hype Cycle: Past, Present, and Future of Regulatory Intelligence Solutions](https://www.freyrregintel.com/navigating-the-ai-hype-cycle-past-present-and-future-of-regulatory-intelligence-solutions/): Artificial Intelligence has never been more talked about or more misunderstood than it is today. The life sciences industry, heavily dependent on accuracy, compliance, and deep domain expertise, is now standing at a pivotal moment: AI is powerful, but only when implemented responsibly, built on the right foundations, and aligned with true regulatory depth.
- [How Regulatory Affairs Teams Use Regulatory Intelligence To Simplify Compliance Management](https://www.freyrregintel.com/how-regulatory-affairs-teams-use-regulatory-intelligence-to-simplify-compliance-management/): A Look at how pharma RI tools for audit-preparation are being revolutionized through automation | Focus on Compliance Management
- [Reimagining Regulatory Affairs with AI-Powered Intelligence](https://www.freyrregintel.com/reimagining-regulatory-affairs-with-ai-powered-intelligence/): Today, we’ve entered the next evolution: AI-powered Regulatory Intelligence.
- [Top 10 Most Asked Questions About Regulatory Intelligence in Life Sciences](https://www.freyrregintel.com/top-10-most-asked-questions-about-regulatory-intelligence-in-life-sciences/): In an industry where regulations shift faster than product pipelines, Regulatory Intelligence has become a necessity. Whether you’re in pharma, medical devices, biologics, or consumer health, staying ahead of evolving global requirements is central to launching safe, compliant, and market-ready products. Yet many teams today still struggle to understand what regulatory intelligence really is, how it works, and why it has become one of the most in-demand capabilities across the life sciences sector.
- [Japan’s Consumer Health & Cosmetics: Why Regulatory Intelligence is Key](https://www.freyrregintel.com/japans-consumer-health-cosmetics-regulations-why-regulatory-intelligence-is-key-for-global-brands/): Japan's consumer health and cosmetics market presents one of the most lucrative, yet at the same time one of the most regulated, markets in the world. To global brands, Japan offers entry into the Asia market. But behind the prestige of such a market lies a maze of regulations and guidances that demand precision, patience, and local expertise/context. To thrive in the Japanese market, companies need to combine the discipline of compliance with Regulatory Intelligence.
- [Agentic AI in Regulatory Intelligence: From Passive Monitoring to Active Compliance](https://www.freyrregintel.com/agentic-ai-in-regulatory-intelligence-from-passive-monitoring-to-active-compliance/): The global life sciences sector deals with a relentless volume of regulations all the time. Regulatory teams in these companies face huge pressure just to stay on top of all the changing rules. It's complicated and takes a lot of time and resources.
- [The Role of AI in Regulatory Intelligence: An In-depth study](https://www.freyrregintel.com/the-role-of-ai-in-regulatory-intelligence-an-in-depth-study/): Pharmaceutical companies have increasingly begun using AI to fast-track the compliance process. Incorporating AI in regulatory intelligence not only saves time and money, but it also prevents from getting tangled in legal hurdles. Every nation and region has its own laws and regulations, with regards to new drugs entering its market. It is therefore imperative for conglomerates to understand and comply accordingly.
- [How Pharma Companies Use Regulatory Intelligence to Accelerate Global Submissions](https://www.freyrregintel.com/how-pharma-companies-use-regulatory-intelligence-to-accelerate-global-submissions/): Regulatory Intelligence in Pharma refers to the continuous process of gathering, analyzing, and applying regulatory data to make informed decisions throughout the drug development and commercialization lifecycle. It empowers regulatory teams to track updates from health authorities, anticipate changes, and align submissions to current standards across multiple markets.
- [Top 10 Features to Look for in Regulatory Intelligence Tools](https://www.freyrregintel.com/top-10-features-to-look-for-in-regulatory-intelligence-tools/): Navigating today’s complex regulatory landscape demands more than spreadsheets and manual monitoring. Whether you're in pharmaceuticals, medical devices, biotechnology, or consumer health, having the right regulatory intelligence tools can ensure faster market access, reduced compliance risk, and better strategic planning.
- [What Is Regulatory Intelligence? A Beginner’s Guide for Life Sciences](https://www.freyrregintel.com/what-is-regulatory-intelligence-a-beginners-guide-for-life-sciences/): Welcome to the step-by-step guide to understanding the role of Regulatory Intelligence software in the industry: Compliance Optimization | Things to knowLearn the status, function and significance of Regulatory Intelligence as a tool in the life sciences and how AI is reshaping the landscape.
- [How to Set Up a Regulatory Intelligence Function in Your Organization](https://www.freyrregintel.com/how-to-set-up-a-regulatory-intelligence-function-in-your-organization/): This guide explores the foundational elements of building a proactive regulatory intelligence function, backed by research and real-world examples.
- [Regulatory Compliance in Healthcare: What It Is and Why It’s Critical for Hospitals and Providers](https://www.freyrregintel.com/regulatory-compliance-in-healthcare-what-it-is-and-why-its-critical-for-hospitals-and-providers/): Understanding healthcare regulatory compliance is tough. In the United States alone, medical facilities and hospitals have over 600 mandatory mandates to contend with. Just staying informed costs organizations around $39 billion in administrative costs each year. 
- [Navigating Japan’s Pharma Regulations in 2025: How RI Helps You Avoid Common Pitfalls](https://www.freyrregintel.com/navigating-japans-pharma-regulations-in-2025-how-ri-helps-you-avoid-common-pitfalls/): Japan’s pharmaceutical regulatory landscape is both mature and fast‑evolving. Companies must align with the Ministry of Health, Labour and Welfare (MHLW) as policymaker and the Pharmaceuticals and Medical Devices Agency (PMDA) as reviewer and safety authority - each with its own procedures, notices, and timelines.
- [Regulatory Intelligence for US Innovator & Generic Pharmaceuticals](https://www.freyrregintel.com/regulatory-intelligence-for-us-pharmaceuticals-generics/): In one of the world’s most tightly regulated and fiercely competitive pharmaceutical markets, compliance isn’t a box to tick, it’s the foundation of market access, reputation, and growth. With over $1 trillion in drug sales projected in the US by 2030, the stakes are high for both innovator (branded) and generic drug manufacturers aiming to capture market share while meeting stringent FDA regulatory requirements at every stage.
- [AI x Regulatory Affairs in Japan: What’s Changing in 2025?](https://www.freyrregintel.com/ai-x-regulatory-affairs-in-japan-whats-changing-in-2025/): In 2025, Japan stands at a significant inflection point in regulatory transformation. For regulatory professionals in the pharmaceutical, medical device, and consumer health sectors, the pressure to stay compliant while improving speed-to-market is intensifying. A series of bold regulatory shifts led by Japan's Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA)—are reshaping how regulatory affairs (RA) teams operate.
- [Medical Device Regulatory Affairs: A Guide to Compliance, MDR Regulations, and Industry Standards](https://www.freyrregintel.com/medical-device-regulatory-affairs-a-guide-to-compliance-mdr-regulations-and-industry-standards/): Freya.Intelligence,  represents a significant advancement in medical device regulatory affairs. This AI-powered platform offers:
- [Top 5 Challenges in Global Regulatory Monitoring](https://www.freyrregintel.com/top-5-challenges-in-global-regulatory-monitoring/): If you work in compliance or regulatory affairs in 2025, you've probably felt a growing sense that the regulatory world is spinning faster than ever before. This isn’t your imagination. What industry experts are calling "regulatory divergence" has created a storm of policy shifts happening simultaneously across multiple countries and regions.
- [How Japanese Medical Device Companies Can Use Regulatory Intelligence for Market Expansion](https://www.freyrregintel.com/how-japanese-medical-device-companies-can-use-regulatory-intelligence-for-market-expansion/): As we navigate through 2025, medical devices companies worldwide are facing an increasingly complex regulatory landscape that demands not just compliance, but strategic foresight. For Japanese medical device manufacturers long celebrated for their precision engineering and methodical approach to quality this presents both an opportunity and a critical challenge.
- [Healthcare Regulatory Agencies: Their Role, Responsibilities, and Key Laws Shaping the Industry](https://www.freyrregintel.com/healthcare-regulatory-agencies-their-role-responsibilities-and-key-laws-shaping-the-industry/): No healthcare system runs without oversight — not in 2025, and certainly not in high-risk environments where patient safety and data integrity are on the line. That’s where healthcare regulatory agencies come in. These government bodies don’t just issue rules; they shape how care is delivered, who gets certified to provide it, and what compliance actually looks like in practice. Their work touches nearly every layer of modern care: from how medications are tracked to how electronic records are stored (and who’s accountable when something goes wrong).
- [What Top Regulatory Teams Are Doing Differently in 2025](https://www.freyrregintel.com/what-top-regulatory-teams-are-doing-differently-in-2025/): If you are from the life sciences industry or you’ve been following the regulatory world, you know it’s never been busier—or more unpredictable. New regulations and guidelines seem to drop every week, and the push for global launches is relentless. As a result of which, today’s most successful Regulatory Affairs teams are shaping strategy and driving business value by bringing innovation in everything they do.
- [Regulatory Disruption and Opportunity: Our Experience at RAPS Regulatory Intelligence Conference 2025](https://www.freyrregintel.com/regulatory-disruption-and-opportunity-our-experience-at-raps-regulatory-intelligence-conference-2025/): The RAPS Regulatory Intelligence Conference 2025 brought together some of the brightest minds in Regulatory Affairs—and was packed with insights, opportunities, and a clear sense of momentum in the industry. For us, it wasn’t just a conference—it was a reaffirmation of our mission to drive Regulatory transformation with intelligent, tech-first solutions.
- [The Future of AI in Healthcare: How Artificial Intelligence is Revolutionizing Medicine](https://www.freyrregintel.com/the-future-of-ai-in-healthcare-how-artificial-intelligence-is-revolutionizing-medicine/): The future of AI in healthcare isn’t theoretical; it’s unfolding now. This article explores how artificial intelligence in healthcare is transforming not only direct patient care but also how AI will change healthcare systems behind the scenes — from R&D to regulatory approval.
- [Economic and Regulatory Shifts: How New US Policies Affect Southeast and Far East Asia](https://www.freyrregintel.com/economic-and-regulatory-shifts-how-new-us-policies-affect-southeast-and-far-east-asia/): The reintroduction of the Production of Lifesaving Supply of Medicines (PILLS) Act is set to reshape the global pharmaceutical landscape. Aimed at reducing foreign dependency and strengthening domestic pharmaceutical manufacturing in the United States of America, this legislation has significant implications for global supply chains.
- [Simplifying Cross-Border Compliance with Regulatory Intelligence](https://www.freyrregintel.com/simplifying-cross-border-compliance-with-regulatory-intelligence/): Innovation knows no boundaries in today's rapidly evolving life sciences landscape. Companies are increasingly operating on a global scale, developing and delivering breakthrough products across multiple jurisdictions.
- [2024 in Review: Redefining Regulatory Intelligence, One Milestone at a Time](https://www.freyrregintel.com/2024-in-review-redefining-regulatory-intelligence-one-milestone-at-a-time/): As the clock ticks into 2025, we’re rolling out our own Year-In-Review—a Freyr GRI special edition that’s part milestone parade, part visionary roadmap, and all about redefining Regulatory Intelligence.
- [MoCRA: A New Era in Global Cosmetic Regulation](https://www.freyrregintel.com/mocra-a-new-era-in-global-cosmetic-regulation/): In December 2022, President Joe Biden signed the Modernization of Cosmetics Regulation Act (MoCRA) into law as part of the Consolidated Appropriations Act, 2023. This was the first piece of cosmetic-regulatory legislation since the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938. MoCRA significantly enhanced the control of the US Food and Drug Administration (FDA) over the cosmetic industry, allowing it to regulate the manufacturing and marketing of cosmetic products as well as be more vigilant of their effects on consumers.   
- [Mastering Regulatory Intelligence: Key Skills for 2025 and Beyond](https://www.freyrregintel.com/mastering-regulatory-intelligence-key-skills-for-2025-and-beyond/): As people in the regulatory field, we’re witnessing ourselves how Regulatory Intelligence is evolving from a "nice-to-have" into a critical business function. With an increasing volume of regulatory changes and the growing importance of compliance, Regulatory Intelligence as a field will soon become indispensable.
- [Beyond Compliance: Key Benefits of Regulatory Intelligence](https://www.freyrregintel.com/beyond-compliance-key-benefits-of-regulatory-intelligence/): To fully leverage the benefits of Regulatory Intelligence, consider the following best practices:
- [Regulatory Intelligence Reimagined: The GenAI Breakthrough](https://www.freyrregintel.com/regulatory-intelligence-reimagined-the-genai-breakthrough/): In today's fast-paced, globally interconnected world, navigating the ever-evolving regulatory landscape has become a formidable challenge for organizations across industries. The traditional approaches to regulatory intelligence (reg intel) – relying heavily on manual processes and outdated systems – have struggled to keep pace with the rapid changes and increasing complexities that define the modern compliance environment.
- [Key Trends shaping the future of Regulatory Intelligence in 2024](https://www.freyrregintel.com/key-trends-shaping-the-future-of-regulatory-intelligence-in-2024/): Imagine a world where regulatory compliance isn't just a checkbox—it's a competitive advantage. Welcome to 2024, where the regulatory intelligence landscape is undergoing a seismic shift. From AI-powered insights to global harmonization efforts, the life sciences industry stands on the brink of a regulatory renaissance.
- [Managing rapidly shifting Regulatory Landscape: Learnings from California Cosmetics Ingredients Ban](https://www.freyrregintel.com/managing-rapidly-shifting-regulatory-landscape-learnings-from-california-cosmetics-ingredients-ban/): In recent months, the cosmetics industry, particularly in the state of California, has undergone a seismic shift. Regulatory authorities have implemented a ban on certain ingredients commonly found in cosmetics products, triggering a ripple effect throughout the supply chain. In this blog post, we delve into the implications of this ban, its global significance, and strategies for proactively adapting to regulatory changes. 
- [Managing Regulatory Compliance of Medical Devices: At the Brink of AI Revolution](https://www.freyrregintel.com/managing-regulatory-compliance-of-medical-devices-at-the-brink-of-ai-revolution/): The fusion of Artificial Intelligence (AI) and Machine Learning (ML) within the medical devices industry is revolutionizing the entire healthcare sector. These advancements promise to improve Quality of Life (QoL), drive efficiencies for Health-care practitioners (HCPs) and result in improved patient outcomes. For instance, AI-powered diagnostics have demonstrated accuracy rates of up to 95%, leading to more precise and timely diagnoses, according to a study published in Nature Medicine.
- [Regulatory Revolution with Freya: Your Guiding light in dark Regulatory complexities](https://www.freyrregintel.com/regulatory-revolution-with-freya-your-guiding-light-in_dark-regulatory-complexities/): In the constantly changing world of regulatory compliance, where complexity reigns, businesses face a challenging task: keeping pace with an ever-changing web of industry regulations. But what if we told you there was a mystical guide to light the way? Meet Freya – Your Regulatory Intelligence Advisor powered by AI, an astonishing creation by FreyrGRI - a leader in regulatory space.
- [Regulatory Intelligence (RI) Meets Artificial Intelligence (AI): A Revolution in the Waiting?](https://www.freyrregintel.com/regulatory-intelligence-ri-meets-artificial-intelligence-ai-a-revolution-in-the-waiting/): Artificial Intelligence (AI) is revolutionizing the world, particularly the Life Sciences domain. Be it large leaps that we have taken in the field of genomics research and drug discovery or large language models such as ChatGPT, which is making inroads into traditionally less-automated areas such as medical transcriptions – one area which remains sheltered from the exponential benefits of Artificial Intelligence (AI) is the domain of Regulatory Intelligence (RI).
- [Chat GPT and Regulatory Intelligence: A Perfect Match?](https://www.freyrregintel.com/chat-gpt-and-regulatory-intelligence-a-perfect-match/): AI has revolutionised multiple facets of regulatory compliance particularly in the domain of life sciences. The disruptive nature of ChatGPT is bound to create waves in the sea of multidimensional regulatory information due to its immense versatility in the ways that it can be useful to its end customers. It is emerging as a potential change agent for the future of the life sciences companies.
- [Stay on Top of New Global Regulatory Guidelines with Data-driven Regulatory Intelligence](https://www.freyrregintel.com/stay-on-top-of-new-global-regulatory-guidelines-with-data-driven-regulatory-intelligence/): Life science companies face massive challenges while constantly staying ahead of dynamic Health Authority (HA) updates. In addition, it requires multiple recurring and time-consuming processes. The traditional exercises are cumbersome and laborious, proving that Regulatory operations are costly, complicated, and slow. The ever-changing sphere of HA regulations makes it arduous to keep track and adapt at the same pace.
- [Regulatory Intelligence in Medical Devices](https://www.freyrregintel.com/regulatory-intelligence-in-medical-devices/): The medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety. In such a scenario, having a better understanding of the medical devices regulatory requirements and access to updated regulatory information to design and implement a strategy can result in reduced costs, time-to-market, and maximum compliance.
- [Automated Regulatory Intelligence (ARI): Keeping you Ahead of the Curve](https://www.freyrregintel.com/automated-regulatory-intelligence-ari-keeping-you-ahead-of-the-curve/): Regulations stand crucial for any industry that functions in the Life Sciences domain, which is the third most heavily regulated sector after the Aviation & Financial sectors. Non-compliance with regulations comes at a high cost – the patients’ lives, heavy economic penalties, or loss of reputation.
- [Regulatory Intelligence (RI): The Focal Point of Your Business](https://www.freyrregintel.com/regulatory-intelligence-ri-the-focal-point-of-your-business/): Introducing innovative products across global marketplaces is imperative for life sciences companies to ensure profitability and maintain their presence in the market. Regulatory compliance and authorizations being the key factors behind any winning launch, inadequate Regulatory information can trigger an increase in costs and time-to-market.

## Pages
- [Freya Intelligence Plus Plan Thank You](https://www.freyrregintel.com/plus-plan-new-thank-you/): You’re just one step away from making your regulatory journey a whole lot efficient. We are so excited to partner with you and help your team thrive!
- [Freya Intelligence Plus Plan](https://www.freyrregintel.com/pricing-plan-plus/)
- [Free Trial Form](https://www.freyrregintel.com/free-trial-form/): Global Regulations Database: Access 95000+ Regulations across 200+ Markets and 100 Product Types with freya.Regulations Dont Search, Just Ask with freya - Your AI First Regulatory Wiz Chat, Summarize, Translate & Compare Regulatory Documents with freya.DocChat Thematic Regulatory Analytics & Visualisation with freya.Dashboards Configurable Regulatory Newsletters with freya.Alerts User Guide, Navigation Videos and Customer Support
- [ribben](https://www.freyrregintel.com/ribben/): ▼ Test Drive Freya, our AI Chatbot - get instant regulatory answers, free and live! TRy Now
- [Frequently Asked Questions](https://www.freyrregintel.com/frequently-asked-questions/): FAQs Business FAQs Technical FAQs Functionality FAQs 01. What is Regulatory Intelligence? Regulatory Intelligence is the process of gathering, analyzing, and applying global regulatory updates to guide informed, compliant, and timely decisions. At Freyr, we turn complex data into strategic insights—keeping your products market-ready and your teams ahead of change. 02. What is freya.Intelligence? freya.Intelligence is Freyr’s AI-powered regulatory intelligence platform designed to simplify global compliance for life sciences. It monitors 95,000+ regulations across 200+ markets and 2,000+ health authorities, delivering real-time insights through smart dashboards, multilingual AI chat, document summarization, and custom alerts—helping you shift from manual tracking to intelligent, proactive decision-making. 03. How many markets does freya.Intelligence cover? freya monitors 200+ markets & 115+ product types—Pharma, Devices, Cosmetics, Food, Chemicals & more—so you never miss a global compliance change. 04. What are the pricing plans for freya.Intelligence? freya.Intelligence starts at $100/user/month with flexible, scalable pricing. Annual discounts & enterprise plans available for all life sciences teams. 05. How can I subscribe to freya.Intelligence? Getting started is simple. Request a demo on freyrregintel.com or via email. Try freya free for 14 days or choose a plan that fits your needs. 06. What are the business support timings? Our support team is available across time zones for seamless help:
7:30 AM–4:30 PM EST 11:30 PM–8:30 AM EST
1:30 AM–10:30 AM EST 07. How can I request an enterprise account? Request an enterprise account via our demo form or email sales@freyrregintel.com. Get advanced features, custom integrations & tailored support. 08. What is the trial period offered for freya.Intelligence? Explore freya.Intelligence with a 14-day free trial post-demo including multi-user access. Request your demo to get started today! 09. What are the payment options available? We accept credit cards, PayPal, and bank transfers—securely processed through encrypted gateways for safe, hassle-free payments. 10. What currency is freya.Intelligence billed in? freya subscriptions are billed in USD, with currency conversion options available based on your location and agreement terms. 11. How can I book a demo for freya.Intelligence? Book a demo at freyrregintel.com or email sales@freyrregintel.com. We’ll schedule a session that fits your team and focus on the features you need most. 01. Can I integrate freya.Intelligence with our exisiting systems? freya integrates smoothly with existing infrastructures, securely incorporating your internal data into segregated environments. This enables fully customized dashboards, regulatory feeds, and intelligence workflows—tailored to your products, markets, and compliance goals for a truly personalized experience. 02. Is freya.Intelligence an on-premise or a cloud based platform? freya.Intelligence is a secure, cloud-based platform hosted on AWS—ISO 27001 certified for enterprise-grade data protection, scalability & remote access with minimal IT effort. 03. Do you have SSO integration capabilities? freya.Intelligence supports secure SSO (Single Sign-On) integration, ensuring centralized authentication and robust access control across your enterprise. By minimizing password-related risks and enforcing enterprise-grade security protocols, SSO helps safeguard your data while delivering seamless user access. Just share your specifications—we’ll handle the secure setup. 04. If there is system error, how can I reach out to the team? For technical help, email our support team at support@freyafusion.com. We'll respond promptly to resolve your issue via email, based on your needs. 05. What if my requrements are very niche and specific? No problem—our experts can help you access highly specific, tailored regulatory data beyond what’s on the platform. Just tell us what you need. 06. If I use freya for my data management, how secure is your data storage and its confidentiality? freya is built with enterprise-grade security at its core. Your data is stored on secure AWS infrastructure, protected with 256-bit encryption and accessed via HTTPS. The platform is ISO 27001, SOC 2, and GDPR-ready, and adheres to OWASP standards. It also supports GxP compliance and aligns with ISO 13485 for medical device quality systems—ensuring both data security and regulatory integrity. 01. How do you monitor regulations on freya.Intelligence? freya combines 2,300+ bots scanning global sites with 850+ experts validating data—ensuring every regulatory update is accurate, relevant, and actionable. 02. Is there any automated way of pulling data from external sources? freya’s smart automation reliably scans over 1,500 health authorities, 200+ trade associations, and 180+ regulatory bodies. It continuously extracts real-time updates from trusted public sources and verified data feeds—ensuring that your compliance insights are not only current and relevant, but also consistently accurate and dependable. 03. Is training provided post-subscription? Yes. freya.Intelligence provides comprehensive training post-subscription.
This includes live onboarding sessions, step-by-step tutorials, user guides, and in-app assistance. Refresher sessions and additional training are available on request. Users are also updated and trained as new features are introduced to ensure seamless adoption. 04. What is the activation time after subscribing to freya.Intelligence? Your freya account is activated within 12 hours on weekdays (48 on weekends). Once onboarded, check your inbox for the activation link. Need it sooner? Just ask! 05. What domains does freya.Intelligence cover? freya tracks 115+ product types globally, across Pharma, Medical Devices, Food, Supplements, Cosmetics & Consumer Goods. 06. Does freya.Intelligence cover Health Authority Communications and News? Yes! freya features a curated section for Health Authority updates & Regulatory News, powered by smart bots and our global Freyr Affiliate network. 07. Do you offer any analytics capabilities, e.g. Power BI Analytics Tool? Yes! freya delivers advanced analytics through AWS QuickSight, with tailored dashboards built to your needs. Track key metrics, monitor trends, and make data-driven decisions—no external tools required. 08. Do you offer any AI-related summarization and/or chat features? Yes, freya.Intelligence offers advanced AI-driven features designed to support users across global markets. Its multilingual regulatory chatbot allows users to ask questions in their local language and receive accurate, easy-to-understand responses. The platform also includes intelligent document search capabilities, enabling precise retrieval of relevant regulations from over 200 markets. Additionally, the Content Partner tool simplifies complex regulatory documents into clear, actionable summaries. Together, these features make navigating compliance faster, smarter, and more user-friendly—no matter where you're located. 09. Ability to for internal stakeholders to conduct impact evaluation and/or provide feedback on document? freya includes a comprehensive Impact Assessment module that enables internal teams to evaluate regulatory changes by scope, priority, and type—whether procedural, labeling, or market-related. Stakeholders can assign tasks, provide feedback through comments, tag responsible teams, and upload supporting documents. Every action is tracked in real time and presented via intuitive dashboards, ensuring complete visibility, traceability, and seamless cross-functional collaboration. 10. Newsletter feature? Custom-curated by company for internal use? Yes! freya offers customizable newsletters tailored by market, domain, product, and topic. Set frequency, rename subscriptions & align to time zones—keeping each team informed with relevant regulatory insights.
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## Pricing Plans
- [Corporate Pricing Plan](https://www.freyrregintel.com/pricing-plan/corporate/): Global Regulations Database: Access 95000+ Regulations across 200+ Markets and 100+ Product Types with freya.Regulations Dont Search, Just Ask with freya - Your AI First Regulatory Wiz Chat, Summarize, Translate & Compare Regulatory Documents with freya.DocChat Thematic Regulatory Analytics & Visualisation with freya.Dashboards Configurable Regulatory Newsletters with freya.Alerts Configurable Workflows & Policy Management with freya.Workflows Secure and Centralised Regulatory Document Management System- freya.Docs Dedicated CSM, Video tutorials, training material and periodic online trainings On Request Automated, Accelerated and Streamlined Responses to Health Authority Queries with freya.RTQ
- [Plus Pricing Plan](https://www.freyrregintel.com/pricing-plan/plus-old/): Global Regulations Database: Access 95000+ Regulations across 200+ Markets and 100+ Product Types with freya.Regulations Dont Search, Just Ask with freya - Your AI First Regulatory Wiz Chat, Summarize, Translate & Compare Regulatory Documents with freya.DocChat Thematic Regulatory Analytics & Visualisation with freya.Dashboards Configurable Regulatory Newsletters with freya.Alerts Customer Support, Video tutorials, training material and one-time online training On Request Automated, Accelerated and Streamlined Responses to Health Authority Queries with freya.RTQ Secure and Centralised Regulatory Document Management System with freya.Docs
- [Standard](https://www.freyrregintel.com/pricing-plan/standard/): Global Regulations Database (180+ Markets, 100+ Product Types) AI-Enabled Regulatory Advisor Chatbot (freya) AI-Enabled Content Partner (Chat, Summarize, Translate, Compare) On Request Video tutorials and Training material, One-time Online training Thematic Regulatory Dashboards (Analytics & Visualization) Regulatory Alerts Regulatory Document Management System (RI Library)
- [Free Trial Plan](https://www.freyrregintel.com/pricing-plan/free-trial/): Global Regulations Database: Access 95000+ Regulations across 200+ Markets and 100 Product Types with freya.Regulations Dont Search, Just Ask with freya - Your AI First Regulatory Wiz Chat, Summarize, Translate & Compare Regulatory Documents with freya.DocChat Thematic Regulatory Analytics & Visualisation with freya.Dashboards Configurable Regulatory Newsletters with freya.Alerts User Guide, Navigation Videos and Customer Support

## Whitepapers
- [EFSA 2026: Navigating the New Food & Feed Application Rules with Regulatory Intelligence](https://www.freyrregintel.com/whitepapers/efsa-2026-navigating-the-new-food-feed-application-rules-with-regulatory-intelligence/): EFSA’s 2026 procedural reforms will fundamentally reshape how non-pesticide (CON) applications are prepared, reviewed, and concluded. Driven by the European Biotech Act and EFSA’s efficiency agenda, the new framework introduces tighter timelines, broader presubmission expectations, and faster consequences for non-compliance—marking a clear shift from procedural flexibility to disciplined, time-bound execution.
- [The EU Pharma Package: Navigating Reform with Regulatory Intelligence](https://www.freyrregintel.com/whitepapers/the-eu-pharma-package-leveraging-regulatory-intelligence-to-navigate-europes-most-comprehensive-pharmaceutical-reform-in-two-decades/): The EU Pharma Package represents the most comprehensive overhaul of European pharmaceutical legislation in over 20 years, redefining how medicines are developed, approved, and distributed across the EU. Announced by the European Commission in April 2023 and endorsed by the Council in June 2025, the reform aims to create a more agile, transparent, and sustainable system that balances innovation, access, and environmental responsibility.
- [Navigating Japan’s New OTC Drug Classifications – Global Lessons for U.S./EU Markets](https://www.freyrregintel.com/whitepapers/navigating-japans-new-otc-drug-classifications-global-lessons-for-u-s-eu-markets/): Abstract
- [Price Pressures, Policy Shifts: Navigating U.S. Pharma’s Regulatory Crossroads](https://www.freyrregintel.com/whitepapers/price-pressures-policy-shifts-navigating-u-s-pharmas-regulatory-crossroads/): Abstract
- [GLP-1 Drugs in India: Using Regulatory Intelligence to Stay Ahead in a Fast-Moving Market](https://www.freyrregintel.com/whitepapers/glp-1-drugs-in-india-using-regulatory-intelligence-to-stay-ahead-in-a-fast-moving-market/): India is emerging as a strategic hub for GLP-1-based therapies amid rising obesity and diabetes rates. With a large treatment-naïve population, evolving regulatory frameworks, and upcoming patent expirations (like semaglutide in 2026), the country offers immense commercial potential for pharmaceutical companies. However, regulatory conservatism, pricing unpredictability, and market complexity pose major challenges.
- [Cross-Border Compliance in Focus: U.S. Pharma & China Biotech](https://www.freyrregintel.com/whitepapers/cross-border-compliance-in-focus-how-u-s-pharma-is-navigating-chinas-biotech-boom-with-regulatory-intelligence/): As China rapidly positions itself as a global biotech leader, U.S. pharmaceutical companies are intensifying their engagement with the Chinese life sciences market through cross-border licensing, co-development partnerships, and early market entry strategies. This whitepaper explores the strategic and regulatory dynamics driving this shift—highlighting China's investment in innovation, modernization of clinical trial infrastructure, and regulatory alignment with international norms.
- [Finding the Needle: Better Regulatory Intelligence in Pharma](https://www.freyrregintel.com/whitepapers/finding-the-needle-the-challenges-and-some-solutions-of-effective-regulatory-intelligence-in-pharma/): In today's increasingly digitized regulatory landscape, Regulatory Intelligence (RI) is no longer about merely retrieving information—it's about identifying the right information at the right time to ensure global compliance and informed decision-making. With over 3 million regulatory documents and publications available across major databases like PubMed, EMA, and FDA, RI professionals face the daunting task of navigating a vast, time-sensitive, and complex ecosystem of data.
- [Automating Global Regulatory Intelligence](https://www.freyrregintel.com/whitepapers/automating-global-regulatory-intelligence/): This whitepaper presents a comprehensive review of recent breakthroughs in automating regulatory intelligence, leveraging cutting-edge technologies including natural language processing, machine learning, and more. By exploring the benefits of this automation, such as heightened efficiency, accuracy, and agility, organizations can gain invaluable insights to remain compliant with evolving regulations. Additionally, this paper addresses the associated challenges and limitations, providing pragmatic recommendations for enterprises aiming to implement automated systems. Ultimately, this whitepaper emphasizes the transformative potential of automating regulatory intelligence, enabling organizations to proactively navigate regulatory changes, ensure compliance, reduce costs, and optimize operational processes.

## Webinars
- [Understanding Cosmetic Compliance in Mexico: Key Regulations & Market Entry Essentials](https://www.freyrregintel.com/webinars/understanding-the-cosmetic-regulatory-landscape-of-mexico/): Thank you for your interest in the Freyr’s Webinar Series (FWS). Here is an archived version of the recently concluded webinar ‘Understanding the Cosmetic Regulatory Landscape of Mexico’ held on June 29, 2023, so you can peruse it at your convenience.
- [Indian Medical Device Regulations: Current Trends & Compliance Essentials](https://www.freyrregintel.com/webinars/indian-medical-device-regulatory-landscape-current-dynamics/): Thank you for your interest in the Freyr’s Webinar Series (FWS). Here is an archived version of the recently concluded webinar  “Indian Medical Device Regulatory Landscape – Current Dynamics,” held on February 22, 2023, so you can peruse it at your convenience.
- [Navigating Australia’s Complementary Medicines Regulations: A Comprehensive Guide](https://www.freyrregintel.com/webinars/regulatory-perspective-of-complementary-medicines-in-australia/): We are happy you are interested in the Freyr’s Webinar Series (FWS). Here is an archived version of the recently concluded webinar ' Regulatory Perspective of Complementary Medicines in Australia’ held on July 27, 2023, so you can peruse it at your convenience.
- [Entering Japan’s Food and Supplement Market: Regulatory Challenges & Proven Solutions](https://www.freyrregintel.com/webinars/food-and-dietary-supplements-market-entry-challenges-and-solutions-japan/): Thank you for your interest in the Freyr’s Webinar Series (FWS). Here is an archived version of the recently concluded webinar 'Food and Dietary Supplements Market Entry Challenges and Solutions - Japan’ held on May 30, 2023, so you can peruse it at your convenience.
- [Building Strategic Regulatory Partnerships: How to Choose and Collaborate with the Right Partner](https://www.freyrregintel.com/webinars/strategic-regulatory-partnerships-how-to-evaluate-engage-with-a-regulatory-partner/): Thank you for your interest in the Freyr’s Webinar Series (FWS). Here is an archived version of the recently concluded webinar “Strategic Regulatory Partnerships - How to Evaluate & Engage with a Regulatory Partner?” held on February 28, 2023, so you can peruse it at your convenience.
- [Understanding UAE Cosmetic Regulations: On-Demand Webinar Access](https://www.freyrregintel.com/webinars/decode-the-cosmetic-regulatory-framework-of-the-uae/): Thank you for your interest in Freyr’s Webinar Series (FWS). Here is an archived version of the recently concluded webinar ‘Decode the Cosmetic Regulatory Framework of the UAE’ held on July 26, 2023, so you can peruse it at your convenience.
- [Mastering Cosmetic Compliance in Japan: From Quasi-Drugs to Market Entry](https://www.freyrregintel.com/webinars/understanding-end-to-end-cosmetic-regulations-in-japan/): Thank you for your interest in the Freyr’s Webinar Series (FWS). Here is an archived version of the recently concluded webinar 'Understanding End-to-End Cosmetic Regulations in Japan’ held on April 04, 2023, so you can peruse it at your convenience.
- [Navigating EU Regulations for Food and Food Supplements: Key Insights from Our Latest Webinar](https://www.freyrregintel.com/webinars/launching-food-supplements-in-eu-countries-germany-france-spain-italy-and-poland/): Thank you for your interest in the Freyr’s Webinar Series (FWS). Here is an archived version of the recently concluded webinar ‘Launching Food Supplements in EU Countries – Germany, France, Spain, Italy, and Poland’ held on February 24, 2023, so you can peruse it at your convenience.

## Industry News
- [FDA Expands Use of Real-World Evidence (RWE) in Medical Device Reviews](https://www.freyrregintel.com/industry-news/fda-expands-use-of-real-world-evidence-rwe-in-medical-device-reviews/): "The U.S. FDA has updated its approach to Real-World Evidence (RWE) by allowing the use of de-identified patient data in drug and medical device application reviews, removing a major barrier to broader RWE adoption.
- [Brexit Impact on Therapeutic Goods Regulation in Australia](https://www.freyrregintel.com/industry-news/brexit-impact-on-therapeutic-goods-regulation-in-australia/): Australia has updated its regulatory framework for therapeutic goods, medicines, and medical devices following Brexit, introducing a new Mutual Recognition Agreement (MRA) with the United Kingdom effective from 01 January 2021.
- [Brazil Law No. 15,404/2026: New Cocoa Content and Chocolate Labelling Requirements](https://www.freyrregintel.com/industry-news/brazil-law-no-15404-2026-new-cocoa-content-and-chocolate-labelling-requirements/): Brazil has enacted Law No. 15,404 (08 May 2026) establishing new regulatory standards for cocoa-derived products and chocolate labeling to improve consumer transparency and product quality.
- [SCCS Working Group Meeting on Cosmetic Ingredients: Key Discussions and Scientific Updates (April 2026)](https://www.freyrregintel.com/industry-news/sccs-working-group-meeting-on-cosmetic-ingredients-key-discussions-and-scientific-updates-april-2026/): The Scientific Committee on Consumer Safety (SCCS) held its Working Group meeting on Cosmetic Ingredients on 21–22 April 2026 in Luxembourg, focusing on the safety evaluation of cosmetic ingredients used across the EU market.
- [EU Proposal to Simplify AI Regulation and Strengthen AI Governance](https://www.freyrregintel.com/industry-news/eu-proposal-to-simplify-ai-regulation-and-strengthen-ai-governance/): The European Union has proposed amendments to the AI Act (EU 2024/1689) and related aviation regulations to simplify implementation of harmonized Artificial Intelligence (AI) rules across the EU.
- [UK Guidance on Exporting Drugs and Medicines Under Special Export Rules](https://www.freyrregintel.com/industry-news/uk-guidance-on-exporting-drugs-and-medicines-under-special-export-rules/): The UK government has updated its guidance on the export of drugs, medicines, and controlled pharmaceutical products, outlining regulatory requirements for human and veterinary medicinal exports.
- [Canada Supplemented Foods Regulations: Definition, Labelling, and Safety Requirements](https://www.freyrregintel.com/industry-news/canada-supplemented-foods-regulations-definition-labelling-and-safety-requirements/): Canada has updated its framework for supplemented foods, clarifying definitions, safety risks, and labelling requirements to protect consumer health.
- [Canada: Rules on Misleading Advertising and Deceptive Marketing for Cosmetics](https://www.freyrregintel.com/industry-news/canada-rules-on-misleading-advertising-and-deceptive-marketing-for-cosmetics/): Canada’s Competition Act strictly regulates misleading advertising and deceptive marketing practices in the cosmetics industry to protect consumers and ensure fair competition.
- [EU SCCS Opinion on BHA in Cosmetics: Safety Limit and Risk Assessment (2026)](https://www.freyrregintel.com/industry-news/eu-sccs-opinion-on-bha-in-cosmetics-safety-limit-and-risk-assessment-2026/): The EU Scientific Committee on Consumer Safety (SCCS) has issued updated guidance on Butylated Hydroxyanisole (BHA), assessing its safety in cosmetic products.
- [EU Health Data Space: New Metadata Requirements for Secondary Use of Health Data (2026)](https://www.freyrregintel.com/industry-news/eu-health-data-space-new-metadata-requirements-for-secondary-use-of-health-data-2026/): The European Commission has proposed new rules under the European Health Data Space (Regulation (EU) 2025/327) to standardize dataset descriptions for the secondary use of electronic health data across EU Member States.
- [Japan IVD Approval Update: Revised Requirements for Clinical Performance Data (2026)](https://www.freyrregintel.com/industry-news/japan-ivd-approval-update-revised-requirements-for-clinical-performance-data-2026/): Japan has introduced a partial revision to the application process for in vitro diagnostics (IVDs), enhancing regulatory flexibility and data requirements under the Pharmaceuticals and Medical Devices Act.
- [Health Canada GUI-0005: Site Master File (SMF) Guidance for Drug Establishments](https://www.freyrregintel.com/industry-news/health-canada-gui-0005-site-master-file-smf-guidance-for-drug-establishments/): Health Canada has updated GUI-0005 guidance to help drug establishments prepare a compliant Site Master File (SMF) in line with Good Manufacturing Practices (GMP) and the Food and Drug Regulations.
- [EU BimmoH: AI-Powered Platform for Human Biology-Based Research Models](https://www.freyrregintel.com/industry-news/eu-bimmoh-ai-powered-platform-for-human-biology-based-research-models/): The European Commission’s Joint Research Centre has launched the Biomedical Models Hub (BimmoH), an AI-driven initiative to build a large-scale dataset of human biology-based models in biomedical research.
- [FDA Form 483 Response Guidance for Drug CGMP Inspections (2026 Update)](https://www.freyrregintel.com/industry-news/fda-form-483-response-guidance-for-drug-cgmp-inspections-2026-update/): The FDA has released guidance to help drug manufacturers effectively respond to Form 483 observations issued after CGMP inspections, ensuring stronger compliance and faster resolution of regulatory issues.
- [PIC/S GMP Annex 6 & Annex 15 Revisions: Public Consultation Open (2026)](https://www.freyrregintel.com/industry-news/pic-s-gmp-annex-6-annex-15-revisions-public-consultation-open-2026/): The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has opened public consultations on proposed updates to GMP Annex 6 and Annex 15, aiming to align manufacturing standards with modern industry practices and quality risk management.
- [Australia: Proposed Amendments to Medical Device Conformity Assessment Procedures](https://www.freyrregintel.com/industry-news/australia-proposed-amendments-to-medical-device-conformity-assessment-procedures/): Australia’s Department of Health has proposed updates to medical device conformity assessment procedures to align with global standards, including the EU MDR and MDSAP. Public consultation is open until 31 March 2026.
- [ANMAT Simplified Authorization Regime for Medical Device Manufacturers and Importers](https://www.freyrregintel.com/industry-news/anmat-simplified-authorization-regime-for-medical-device-manufacturers-and-importers/): Argentina’s ANMAT has introduced a simplified authorization regime under Provision No. 8799/2025 for establishments manufacturing or importing low-risk medical devices, including Class I and II devices and Class A and B IVDs.
- [Colorado House Bill 1139: Regulating AI Use in Healthcare Decisions](https://www.freyrregintel.com/industry-news/colorado-house-bill-1139-regulating-ai-use-in-healthcare-decisions/): Colorado House Bill 1139 introduces new regulations to govern the use of artificial intelligence (AI) in healthcare, ensuring patient safety, transparency, and human oversight in clinical decision-making.
- [EU SCoPAFF March 2026: Pesticide Regulation Concerns and PAN Europe Position](https://www.freyrregintel.com/industry-news/eu-scopaff-march-2026-pesticide-regulation-concerns-and-pan-europe-position/): At the March 2026 SCoPAFF meeting, concerns were raised over proposed EU pesticide regulations, with PAN Europe highlighting potential risks to human health and environmental protection.
- [FDA Adverse Event Monitoring System (AEMS): Unified Safety Reporting Platform](https://www.freyrregintel.com/industry-news/fda-adverse-event-monitoring-system-aems-unified-safety-reporting-platform/): The FDA Adverse Event Monitoring System (AEMS) is a centralized platform designed to streamline adverse event reporting across all FDA-regulated products. It improves safety monitoring, data quality, and regulatory transparency.
- [China: Revised Draft Regulations for Filing and Management of Imported Food Importers and Exporters](https://www.freyrregintel.com/industry-news/china-revised-draft-regulations-for-filing-and-management-of-imported-food-importers-and-exporters/): China’s General Administration of Customs (GACC) has released a revised draft regulation to strengthen food safety, importer/exporter registration, and traceability of imported food products. Public comments are open until 30 April 2026.
- [UK: Cosmetic Products Regulation (EC) No 1223/2009 – Amendment & Transitional Provisions (No. 2) Regulations 2026](https://www.freyrregintel.com/industry-news/uk-cosmetic-products-regulation-ec-no-1223-2009-amendment-transitional-provisions-no-2-regulations-2026/): The 2026 amendments to the Cosmetic Products Regulation (EC) No 1223/2009 introduce new restrictions on chemical substances, aligning with updated safety classifications under the CLP Regulation (EC) No 1272/2008. These changes strengthen controls on carcinogenic, mutagenic, and toxic for reproduction (CMR) substances in cosmetic products.
- [Chile: New Requirements Under Single-Use Plastics Law (Law No. 21,368) Now in Effect](https://www.freyrregintel.com/industry-news/chile-new-requirements-under-single-use-plastics-law-law-no-21368-now-in-effect/): Chile’s Law No. 21,368 introduces strengthened measures to reduce single-use plastics and regulate plastic bottles, supporting environmental protection and waste reduction goals. Published on 13 August 2021, the law follows a phased implementation schedule, with key obligations now approaching full enforcement.
- [Maryland SB 570 & Connecticut SB 118: Baby Food Testing and Toxic Heavy Metals Compliance](https://www.freyrregintel.com/industry-news/maryland-sb-570-connecticut-sb-118-baby-food-testing-and-toxic-heavy-metals-compliance/): Maryland Senate Bill 570 and Connecticut Senate Bill 118 introduce stricter safety requirements for baby food products, targeting toxic heavy metals including arsenic, cadmium, lead, and mercury. Both laws align state-level oversight with U.S. FDA limits to strengthen consumer protection for children under two years of age.
- [Canada: Updated Medical Devices Regulations (SOR/98-282)](https://www.freyrregintel.com/industry-news/canada-updated-medical-devices-regulations-sor-98-282/): Health Canada has released the consolidated Medical Devices Regulations (SOR/98-282) incorporating amendments under SOR/2024-238, with key changes effective 01 January 2026. The updated framework strengthens regulatory oversight, recall authority, and post-market controls for medical devices in Canada.
- [FDA Design Control Guidance for Medical Device Manufacturers (Withdrawn)](https://www.freyrregintel.com/industry-news/fda-design-control-guidance-for-medical-device-manufacturers-withdrawn/): The withdrawn FDA Design Control Guidance provided foundational direction for medical device manufacturers on implementing design control requirements under U.S. quality system regulations. The guidance aimed to strengthen product quality, regulatory compliance, and patient safety throughout the device lifecycle.
- [IVDR Guidance: Demonstrating Safety and Performance for Combined Reagent Devices](https://www.freyrregintel.com/industry-news/ivdr-guidance-demonstrating-safety-and-performance-for-combined-reagent-devices/): Notified Bodies have aligned expectations on how manufacturers must demonstrate the safety, compatibility, and performance of reagent devices used in combination with other devices or equipment under Regulation (EU) 2017/746 (IVDR).
- [Malaysia Mandates DEG and EG Testing for Oral Liquid Medicines](https://www.freyrregintel.com/industry-news/malaysia-mandates-deg-and-eg-testing-for-oral-liquid-medicines/): Malaysia’s Ministry of Health has issued Directive No. 8 of 2026, introducing mandatory testing requirements for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in oral liquid medicinal products. The directive responds to global safety concerns following WHO reports of DEG/EG contamination, linked to over 300 child fatalities worldwide between 2022 and 2023.
- [UK: Guidance on Updates to CIR 520/2012 for Marketing Authorisation Holders](https://www.freyrregintel.com/industry-news/uk-guidance-on-updates-to-cir-520-2012-for-marketing-authorisation-holders/): The European Commission has adopted Commission Implementing Regulation (EU) 2025/1466, amending CIR 520/2012, with most provisions taking effect on 12 February 2026. Certain updates (Article 1, points 7 and 9) have applied since 12 August 2025.
- [EDQM Strengthens e-Submission Rules for CEP Applications](https://www.freyrregintel.com/industry-news/edqm-strengthens-e-submission-rules-for-cep-applications/): The European Directorate for the Quality of Medicines & HealthCare (EDQM) has reinforced its automated system for Certificate of Suitability (CEP) e-submissions, improving efficiency and compliance in regulatory processing. Automation has been live since 01 November 2025, but approximately 25% of submissions remain non-compliant due to missing or invalid eCTD validation reports.
- [EU: Updated Annex II Expands List of Prohibited Substances in Cosmetics](https://www.freyrregintel.com/industry-news/eu-updated-annex-ii-expands-list-of-prohibited-substances-in-cosmetics/): The European Commission has issued a major update to Annex II of Regulation (EC) No 1223/2009, which lists substances prohibited in cosmetic products across all 27 EU Member States. The January 2026 revision strengthens consumer safety by expanding and clarifying chemical restrictions under Article 54(1) LGV.
- [Australia: TGA Targets Non-Compliant Sunscreen Labelling Practices](https://www.freyrregintel.com/industry-news/australia-tga-targets-non-compliant-sunscreen-labelling-practices/): The Therapeutic Goods Administration (TGA) has issued a statement addressing non-compliant sunscreen labelling in Australia, where some products share the same AUST number but differ in name or intended use. Such inconsistencies breach ARTG listing requirements and may result in product withdrawals and regulatory penalties.
- [Europe: New EN 17826 Standard Strengthens Chemical Safety in Baby Care Products](https://www.freyrregintel.com/industry-news/europe-new-en-17826-standard-strengthens-chemical-safety-in-baby-care-products/): The European Committee for Standardization (CEN) has introduced EN 17826, a new harmonized standard across 27 EU markets to enhance chemical safety in baby and childcare products. This regulation complements the General Product Safety Regulation (GPSR – EU 2023/988) by setting stricter controls on hazardous substances that may affect children’s health.
- [EU: EFSA Guidance on Scientific Data Requirements for Food Additive Authorisation](https://www.freyrregintel.com/industry-news/eu-efsa-guidance-on-scientific-data-requirements-for-food-additive-authorisation/): The European Food Safety Authority (EFSA) has issued updated guidance under Regulation (EC) No 1331/2008 outlining the scientific data requirements for authorising or modifying food additives in the EU. The document supports applicants in preparing comprehensive safety dossiers for both new and existing additives.
- [Malaysia: Guideline for Registration of Drug–Medical Device Combination Products](https://www.freyrregintel.com/industry-news/malaysia-guideline-for-registration-of-drug-medical-device-combination-products/): The National Pharmaceutical Regulatory Agency (NPRA) and Medical Device Authority (MDA) have released updated Guidelines for the Registration of Drug–Medical Device and Medical Device–Drug Combination Products in Malaysia. The revision, dated 22 January 2026, introduces the “Bayar Now” payment option, replacing bank drafts for endorsement letter applications.
- [WHO: Technical Requirements for Pharmaceuticals and Medical Devices in ITBs and RFPs](https://www.freyrregintel.com/industry-news/who-technical-requirements-for-pharmaceuticals-and-medical-devices-in-itbs-and-rfps/): The World Health Organization (WHO) outlines strict technical and regulatory requirements for pharmaceuticals and medical devices included in Invitations to Bid (ITBs) and Requests for Proposals (RFPs) to ensure global product quality, safety, and compliance.
- [Saudi Arabia: Updated Guidelines for Advertising Pharmaceutical and Herbal Products](https://www.freyrregintel.com/industry-news/saudi-arabia-updated-guidelines-for-advertising-pharmaceutical-and-herbal-products/): The Saudi Food and Drug Authority (SFDA) has released updated Guidelines for Advertising Conditions and Requirements for Pharmaceutical and Herbal Products, defining procedures for obtaining and maintaining advertising licenses.
- [Australia: TGA’s C1 Application Checklist for OTC Medicines](https://www.freyrregintel.com/industry-news/australia-tgas-c1-application-checklist-for-otc-medicines/): The Therapeutic Goods Administration (TGA) has introduced a C1 Application Checklist to help sponsors submit complete and compliant change applications for registered over-the-counter (OTC) medicines.
- [MedTech Mitra’s IVD Innovators Handbook: A Roadmap for India’s MedTech Future](https://www.freyrregintel.com/industry-news/medtech-mitras-ivd-innovators-handbook-a-roadmap-for-indias-medtech-future/): The MedTech Mitra’s In-Vitro Diagnostic (IVD) Innovators Handbook serves as a comprehensive guide for Indian innovators developing, validating, and commercializing diagnostic devices. It focuses on regulatory compliance, quality management, and market preparedness, ensuring innovations meet global standards.
- [France Clarifies Labeling and Claim Rules for Cosmetic Products](https://www.freyrregintel.com/industry-news/france-clarifies-labeling-and-claim-rules-for-cosmetic-products/): France has reaffirmed its commitment to transparent and accurate cosmetic labeling in alignment with EU Regulation (EC) No. 1223/2009, ensuring that product claims are truthful, verifiable, and not misleading.
- [Indonesia Revises Safety and Quality Rules for Natural Ingredient Drugs](https://www.freyrregintel.com/industry-news/indonesia-revises-safety-and-quality-rules-for-natural-ingredient-drugs/): Indonesia’s National Agency of Drug and Food Control (BPOM) has released a compilation of public input on the draft revision of Regulation No. 29 of 2023, which sets updated safety and quality standards for natural ingredient drugs.
- [EU Proposes Simplified Regulations for Medical Devices and IVDs](https://www.freyrregintel.com/industry-news/eu-proposes-simplified-regulations-for-medical-devices-and-ivds/): The European Commission has proposed amendments to Regulations (EU) 2017/745 and (EU) 2017/746 to streamline compliance processes for medical devices and in vitro diagnostic devices (IVDs) while maintaining high safety and public health standards.
- [FDA Report Highlights PFAS Use and Risks in U.S. Cosmetics](https://www.freyrregintel.com/industry-news/fda-report-highlights-pfas-use-and-risks-in-u-s-cosmetics/): The U.S. Food and Drug Administration (FDA) has released a report assessing the use of Per- and Polyfluoroalkyl Substances (PFAS) in cosmetic products, examining their functions, prevalence, and potential health risks.
- [Canada Proposes Amendments to Single-Use Plastics Regulations](https://www.freyrregintel.com/industry-news/canada-proposes-amendments-to-single-use-plastics-regulations/): Environment and Climate Change Canada has opened consultations on proposed amendments to the Single-use Plastics Prohibition Regulations, allowing the export of certain plastic products while maintaining environmental safeguards.
- [New Quality Management System Certification Rules Effective January 2026](https://www.freyrregintel.com/industry-news/new-quality-management-system-certification-rules-effective-january-2026/): Starting January 1, 2026, the updated Quality Management System (QMS) Certification Rules will take effect, introducing stricter standards for certification bodies, auditors, and industry-specific quality management certifications.
- [FDA Considers Labeling Change for DSHEA Disclaimer on Dietary Supplements](https://www.freyrregintel.com/industry-news/fda-considers-labeling-change-for-dshea-disclaimer-on-dietary-supplements/): The U.S. Food and Drug Administration (FDA) has announced plans to revise labeling requirements for dietary supplements under 21 CFR 101.93(d), which governs the placement of the DSHEA disclaimer — “This statement has not been evaluated by the FDA.”
- [EU Guideline Annex on Excipients in Medicinal Products – Updated for 2025](https://www.freyrregintel.com/industry-news/eu-guideline-annex-on-excipients-in-medicinal-products-updated-for-2025/): The European Commission’s updated annex to the Guideline on Excipients in the Labelling and Package Leaflet of Medicinal Products for Human Use (SANTE-2017-11668) details safety and labeling requirements for excipients used in medicines. Now available in 26 languages and adopted by Australia’s TGA in June 2024, the update strengthens communication on excipient-related risks, thresholds, and mandatory warnings.
- [Ontario’s Medical Radiation and Imaging Technology Act: Defining Standards for Safe Practice and Governance](https://www.freyrregintel.com/industry-news/ontarios-medical-radiation-and-imaging-technology-act-defining-standards-for-safe-practice-and-governance/): The Medical Radiation and Imaging Technology Act, 2017 regulates the practice, qualifications, and governance of medical radiation and imaging technologists in Ontario. The Act establishes professional standards, authorized procedures, and the structure of the College of Medical Radiation and Imaging Technologists.
- [EMA Updates Good Pharmacovigilance Practices (GVP) Guidelines for Enhanced Drug Safety Oversight](https://www.freyrregintel.com/industry-news/ema-updates-good-pharmacovigilance-practices-gvp-guidelines-for-enhanced-drug-safety-oversight/): The European Medicines Agency (EMA) has reaffirmed its commitment to patient safety through the Guidelines on Good Pharmacovigilance Practices (GVP)—a framework for monitoring, detecting, and preventing adverse effects of medicines across the European Union (EU).
- [TGA Updates Acceptable Intake (AI) Limits for Nitrosamine Impurities in Medicines](https://www.freyrregintel.com/industry-news/tga-updates-acceptable-intake-ai-limits-for-nitrosamine-impurities-in-medicines/): The Therapeutic Goods Administration (TGA) has updated the Acceptable Intake (AI) limits for various nitrosamine and nitroso-structured impurities in medicines to strengthen safety standards and risk management across the pharmaceutical sector.
- [TGA Updates Guidance on Advertising Therapeutic Goods on Social Media](https://www.freyrregintel.com/industry-news/tga-updates-guidance-on-advertising-therapeutic-goods-on-social-media/): The Therapeutic Goods Administration (TGA) has updated its guidance to help advertisers, influencers, and businesses comply with Australian laws for promoting therapeutic goods—including medicines, medical devices, and health-related products—on social media platforms.
- [Brazil’s ANVISA Expands List of Prohibited Substances in Cosmetics and Personal Care Products](https://www.freyrregintel.com/industry-news/brazils-anvisa-expands-list-of-prohibited-substances-in-cosmetics-and-personal-care-products/): The National Health Surveillance Agency (ANVISA) has issued Resolution RDC No. 995 of October 30, 2025, updating its list of substances prohibited in personal hygiene products, cosmetics, and perfumes.
- [EU Regulation Denies Health Claim for Citicoline and Memory Function](https://www.freyrregintel.com/industry-news/eu-regulation-denies-health-claim-for-citicoline-and-memory-function/): Effective November 26, 2025, the European Commission has adopted Regulation (EU) 2025/2223, refusing authorization for a health claim linking citicoline to improved memory function in healthy middle-aged and elderly adults.
- [Germany Introduces 500-Gram Threshold for Single-Use Plastic Packaging](https://www.freyrregintel.com/industry-news/germany-introduces-500-gram-threshold-for-single-use-plastic-packaging/): The German Federal Environment Agency (UBA) has revised packaging regulations under the Single-Use Plastics Fund Act (EWKBofdsG), introducing a 500-gram threshold for certain products such as bags, film packaging, and food containers. Packaging that exceeds this weight limit will now be exempt from the levy imposed by the Act.
- [Japan MHLW Announces Approval of New Medical Devices Under National Regulatory Framework](https://www.freyrregintel.com/industry-news/japan-mhlw-announces-approval-of-new-medical-devices-under-national-regulatory-framework/): The Japanese Ministry of Health, Labour and Welfare (MHLW) has officially announced the approval of new medical devices under the Act on Ensuring the Quality, Efficacy, and Safety of Pharmaceuticals and Medical Devices (Act No.145 of 1960). The notification, issued to regional health and pharmaceutical authorities, highlights multiple new device approvals across diverse therapeutic areas.
- [Thailand Establishes New Industrial Standards for Alternative Sterilization Processes in Healthcare Products](https://www.freyrregintel.com/industry-news/thailand-establishes-new-industrial-standards-for-alternative-sterilization-processes-in-healthcare-products/): The Ministry of Industry has issued a new standard — Industrial Product Standards for Sterilization Processes for Healthcare Products, Volume 7: Alternative Processes for Medical Devices and Combined Products, B.E. 2025 — to strengthen sterilization quality and safety for medical devices and combination products that cannot undergo final sterilization.Key Highlights
- [UK MHRA Updates Medical Device Registration Guidance and Fees](https://www.freyrregintel.com/industry-news/uk-mhra-updates-medical-device-registration-guidance-and-fees/): The Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance on medical device registration requirements for placing devices on the market in the UK and Northern Ireland. The guidance outlines obligations for manufacturers, authorized representatives, and responsible persons, with specific requirements based on device class and location.
- [European Commission Launches AI Act Service Desk and Single Information Platform](https://www.freyrregintel.com/industry-news/european-commission-launches-ai-act-service-desk-and-single-information-platform/): The European Commission has launched the AI Act Service Desk and AI Act Single Information Platform to support the effective implementation of the EU Artificial Intelligence Act, which entered into force on 01-Aug-2024. This initiative aims to provide legal clarity, promote trustworthy AI, and drive innovation across Europe.
- [EU AI Act: Key Insights on Training Compute Thresholds for GPAI Models](https://www.freyrregintel.com/industry-news/eu-ai-act-key-insights-on-training-compute-thresholds-for-gpai-models/): The European Union’s Artificial Intelligence (AI) Act, effective August 2024, establishes a regulatory framework to promote trustworthy AI innovation while safeguarding health, safety, and fundamental rights. Under Chapter V, effective from August 2025, providers of General-Purpose AI (GPAI) models—especially those posing systemic risks—must comply with strict documentation and transparency obligations.
- [Saudi Arabia Updates Advertising Requirements for Pharmaceuticals and Herbal Products](https://www.freyrregintel.com/industry-news/saudi-arabia-updates-advertising-requirements-for-pharmaceuticals-and-herbal-products/): The Saudi Food and Drug Authority (SFDA) has released an updated guide on advertising conditions and requirements for pharmaceutical and herbal products, with a public survey open from 09-Oct-2025 to 23-Oct-2025.
- [EDQM Introduces Reliance and Fast-Track Processes for CEP Applications](https://www.freyrregintel.com/industry-news/edqm-introduces-reliance-and-fast-track-processes-for-cep-applications/): The European Directorate for the Quality of Medicines & HealthCare (EDQM) has announced new reliance-based and fast-track assessment initiatives within the Certificates of Suitability (CEP) procedure. These efforts aim to streamline regulatory processes, strengthen collaboration among authorities, and ensure faster access to quality-assured medicines.
- [Indonesia Issues Draft Regulation on GMP and GDP Certification for Pharmaceuticals](https://www.freyrregintel.com/industry-news/indonesia-issues-draft-regulation-on-gmp-and-gdp-certification-for-pharmaceuticals/): The Indonesian Food and Drug Monitoring Agency (BPOM) has released a draft regulation on the certification of Good Manufacturing Practices (CPOB) and Good Distribution Practices (CDOB) for pharmaceutical products. The draft is open for public comment until 17-Oct-2025.
- [EMA Updates Guidance on Nitrosamine Impurity Control in Human Medicinal Products](https://www.freyrregintel.com/industry-news/ema-updates-guidance-on-nitrosamine-impurity-control-in-human-medicinal-products/): The European Medicines Agency (EMA) has updated its Q&A guidance for Marketing Authorization Holders (MAHs) and applicants on managing and preventing nitrosamine impurities in human medicines. The guidance is based on the CHMP Article 5(3) opinion under Regulation (EC) No 726/2004 and outlines best practices for risk evaluation, testing, and mitigation.
- [Guidance on Managing Nitrosamine Risk in Listed Medicines](https://www.freyrregintel.com/industry-news/guidance-on-managing-nitrosamine-risk-in-listed-medicines/): The Therapeutic Goods Administration (TGA) has issued guidance for sponsors and manufacturers on identifying and managing the risk of nitrosamine contamination in listed medicines. Nitrosamines are chemical impurities that can form when nitrates or nitrites react with amines, potentially posing health risks if not properly controlled.
- [ANSES Publishes 2024 Contributions to SCCS Consultations on Cosmetic Substance Risk Assessments](https://www.freyrregintel.com/industry-news/anses-publishes-2024-contributions-to-sccs-consultations-on-cosmetic-substance-risk-assessments/): The French National Agency for Food, Environmental and Occupational Health Safety (ANSES) has released its 2024 report detailing contributions to the European Commission’s Scientific Committee on Consumer Safety (SCCS) consultations on cosmetic substance risk assessments.
- [OPSS Issues Call for Scientific Data on Cosmetic Ingredient Safety](https://www.freyrregintel.com/industry-news/opss-issues-call-for-scientific-data-on-cosmetic-ingredient-safety/): The UK Office for Product Safety and Standards (OPSS) has launched a call for scientific data to assess the safety of certain cosmetic ingredients, including prostaglandins, arbutins, and vitamin A derivatives. Submissions are due by April 30, 2025, and all confidential information must be clearly marked to comply with the Freedom of Information Act.
- [Spain’s 2024 Market Monitoring Report Highlights Strong Oversight of Cosmetic Products](https://www.freyrregintel.com/industry-news/spains-2024-market-monitoring-report-highlights-strong-oversight-of-cosmetic-products/): The Spanish Agency for Medicines and Health Products (AEMPS) has released its 2024 Market Monitoring Report on cosmetic products, emphasizing rigorous oversight to ensure compliance with Regulation (EC) No 1223/2009 and Royal Decree 85/2018.
- [Massachusetts Advances Bill to Ban Animal Testing in Cosmetics and Household Products](https://www.freyrregintel.com/industry-news/massachusetts-advances-bill-to-ban-animal-testing-in-cosmetics-and-household-products/): The Massachusetts Senate Bill 640, titled “An Act Promoting Humane Cosmetics and Other Household Products by Limiting the Use of Animal Testing,” seeks to end traditional animal testing for cosmetics and household goods across the Commonwealth.
- [EU Member States Tighten Rules on Energy Drink Sales to Minors](https://www.freyrregintel.com/industry-news/eu-member-states-tighten-rules-on-energy-drink-sales-to-minors/): While the European Union has no bloc-wide ban on the sale of energy drinks to minors, several member states have introduced national restrictions to curb youth consumption due to health concerns linked to high caffeine and sugar levels.
- [UK Proposes Ban on Bisphenol A (BPA) in Food Contact Materials](https://www.freyrregintel.com/industry-news/uk-proposes-ban-on-bisphenol-a-bpa-in-food-contact-materials/): The Food Standards Agency (FSA) has launched a public consultation (2 Oct–24 Dec 2025) on a proposed ban of Bisphenol A (BPA) and related bisphenols in Food Contact Materials (FCMs) across England, Wales, and Northern Ireland.
- [African Union Opposes Mandatory ‘Country of Harvest’ Labelling for Spices](https://www.freyrregintel.com/industry-news/african-union-opposes-mandatory-country-of-harvest-labelling-for-spices/): The African Union (AU) has formally opposed the proposal for mandatory “country of harvest” labelling in Codex spice standards, citing a lack of technical and economic justification.
- [Slovenia Aligns Tobacco Health Warnings with EU Standards](https://www.freyrregintel.com/industry-news/slovenia-aligns-tobacco-health-warnings-with-eu-standards/): Slovenia’s Health Minister has implemented a new Policy on Health Warnings for Tobacco Products to standardize the placement and design of health warnings on tobacco packaging, ensuring full compliance with EU tobacco labeling directives.
- [Japan Strengthens Safety Rules for Infant Bed Guards and Strollers](https://www.freyrregintel.com/industry-news/japan-strengthens-safety-rules-for-infant-bed-guards-and-strollers/): Japan has proposed an amendment to the Consumer Product Safety Act to enhance safety standards for infant bed guards and strollers, following reports of serious accidents and fatalities involving infants under 18 months.
- [The Role of AI in Regulatory Intelligence: An In-depth study](https://www.freyrregintel.com/industry-news/__trashed-11/): Effective 7 October 2025, Germany’s Battery Law Implementation Act (BattDG) establishes a national framework to complement the EU Battery Regulation and enhance battery waste management and producer responsibility.
- [Regarding Corrections to “Conformity Checklist for Designated Highly Controlled Medical Devices, etc. (Part 31)](https://www.freyrregintel.com/industry-news/regarding-corrections-to-conformity-checklist-for-designated-highly-controlled-medical-devices-etc-part-31/): Correction to the Conformity Checklist for Designated Highly Controlled Medical Devices
- [Code of Ethics for the Practice of Marketing Medical Devices and Supplies in the Kingdom of Saudi Arabia](https://www.freyrregintel.com/industry-news/code-of-ethics-for-the-practice-of-marketing-medical-devices-and-supplies-in-the-kingdom-of-saudi-arabia/): Ethical Marketing Practices for Medical Devices in Saudi Arabia
- [How to Submit a Custom-made Medical Device Notification: Step by Step Guide to Submitting a Custom-Made Medical Device (CMMD) Notification](https://www.freyrregintel.com/industry-news/how-to-submit-a-custom-made-medical-device-notification-step-by-step-guide-to-submitting-a-custom-made-medical-device-cmmd-notification/): Guide for Submitting Custom-Made and Patient-Matched Medical Device Notifications
- [Public Comment Draft Guidance Document Control of Obsolete and Discontinued Medical Device in Healthcare or Related Facilities](https://www.freyrregintel.com/industry-news/public-comment-draft-guidance-document-control-of-obsolete-and-discontinued-medical-device-in-healthcare-or-related-facilities/): Malaysia’s Medical Device Authority Guidance on Obsolete and Discontinued Medical Devices
- [Guideline for the Sealing and Unsealing of Hazardous Substances](https://www.freyrregintel.com/industry-news/guideline-for-the-sealing-and-unsealing-of-hazardous-substances/): Hazardous Substance Act, 15 of 1973: Guidelines for Sealing and Unsealing Hazardous Substances
- [Mandatory Requirements for an Effective Over-the-counter Medicines Application](https://www.freyrregintel.com/industry-news/mandatory-requirements-for-an-effective-over-the-counter-medicines-application/): Therapeutic Goods (Groups) Order No. 1 of 2001 - OTC Medicine Registration Guidelines
- [Announcement to Product Registration Holders (PRHs): Pilot Project for Post-Approval Changes (Variation) Using Reliance](https://www.freyrregintel.com/industry-news/announcement-to-product-registration-holders-prhs-pilot-project-for-post-approval-changes-variation-using-reliance/): NPRA Pilot Project on Post-Approval Changes in Product Registration
- [Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments](https://www.freyrregintel.com/industry-news/patient-focused-drug-development-workshop-to-discuss-methodologic-and-other-challenges-related-to-patient-experience-data-public-workshop-request-for-comments/): "Guidelines for Drug Information on Pharmaceuticals for Human Use
- [Guidance Providing an Overview of Listed Medicines and Listed Assessed Medicines Pathways and Legislative Requirements: Understanding the Legislative Framework for Listed Medicines](https://www.freyrregintel.com/industry-news/guidance-providing-an-overview-of-listed-medicines-and-listed-assessed-medicines-pathways-and-legislative-requirements-understanding-the-legislative-framework-for-listed-medicines/): Guidance Providing an Overview of Listed Medicines and Listed Assessed Medicines Pathways and Legislative Requirements: Understanding the Legislative Framework for Listed Medicines
- [Guidelines for using the ‘TGA Assessed’ Claim on Labels for Assessed Listed Medicines and Registered Complementary Medicines: Using the ‘TGA Assessed’ Claim on Medicine Labels](https://www.freyrregintel.com/industry-news/guidelines-for-using-the-tga-assessed-claim-on-labels-for-assessed-listed-medicines-and-registered-complementary-medicines-using-the-tga-assessed-claim-on-medicine-labels/): Swissmedic Application Process for Establishment Licenses
- [Guidance Document Application Establishment Licence for Medicinal Products or TpP/GT/GMO](https://www.freyrregintel.com/industry-news/guidance-document-application-establishment-licence-for-medicinal-products-or-tpp-gt-gmo/): Swissmedic Application Process for Establishment Licenses
- [Guidance: Early Access to Medicines Scheme – Information for Applicants](https://www.freyrregintel.com/industry-news/guidance-early-access-to-medicines-scheme-information-for-applicants/): NPRA Pilot Project on Post-Approval Changes in Product Registration
- [Guidance Document: Product Information for Human Medicinal Products](https://www.freyrregintel.com/industry-news/guidance-document-product-information-for-human-medicinal-products/): Updated Guidelines for Drug Information on Pharmaceuticals 
- [New EDQM “Guidelines on Medication Review” Just Released](https://www.freyrregintel.com/industry-news/new-edqm-guidelines-on-medication-review-just-released/): The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released new guidelines on medication review to optimize medicine use and enhance patient health outcomes. These guidelines aim to:
- [The Regulations of the Swedish Medicines Agency on Trade in Certain Over-the-counter Medicines (HSLF-FS 2024:27)](https://www.freyrregintel.com/industry-news/the-regulations-of-the-swedish-medicines-agency-on-trade-in-certain-over-the-counter-medicines-hslf-fs-202427/): The regulations will take effect on 01-Nov-2025, with specific deadlines set for compliance.

## Policy & Perspectives
- [Microplastics in the Food Chain: Between Scientific Evidence and Regulatory Action](https://www.freyrregintel.com/policy-perspective/microplastics-in-the-food-chain-between-scientific-evidence-and-regulatory-action/): You have probably heard the headline that microplastics are everywhere: in the ocean, in the air, in table salt, and yes, in human blood and placentas. But for regulatory affairs professionals, the conversation needs to go much further than awareness. This article is structured in two acts: an explainer for anyone new to the topic, followed by an operational deep dive into the regulatory obligations taking shape right now.
- [From Chemicals Regulation to Cosmetics Compliance: Managing Cross-Regulatory Dependencies](https://www.freyrregintel.com/policy-perspective/from-chemicals-regulation-to-cosmetics-compliance-managing-cross-regulatory-dependencies/): Per- and polyfluoroalkyl substances (PFAS) have become a focal point of regulatory, environmental, and commercial scrutiny in Europe. While PFAS were historically valued for their functional performance in cosmetics, particularly in long-lasting, water-resistant, and sensory-enhancing applications, the European regulatory approach has shifted toward class-based restriction and long-term phase-out. This shift is occurring primarily through chemicals and environmental regulation rather than cosmetics-specific legislation, creating structural implications for cosmetics companies operating in or supplying to the European market.
- [Vape Bans & Tax Reforms: Europe’s Changing Nicotine Regulations](https://www.freyrregintel.com/policy-perspective/from-disposable-vape-bans-to-tax-reform-understanding-europes-changing-approach-to-nicotine-products/): Europe’s nicotine market is entering a new regulatory era marked by unprecedented convergence between national bans and EU-wide fiscal reform. From France and Belgium’s bans on disposable vapes to Spain’s sweeping controls on flavours and nicotine pouches, governments are acting rapidly to address youth use, environmental waste, and public health risks. At the same time, the European Commission’s proposed Tobacco Tax Directive (TTD) aims to harmonize excise duties on e-cigarettes, heated tobacco, and nicotine pouches—introducing consistent taxation across Member States by 2028.
- [Navigating the Evolving Landscape: Impact of ICH M4Q(R2) for Life Sciences Organizations](https://www.freyrregintel.com/policy-perspective/navigating-the-evolving-regulatory-landscape-impact-of-ich-m4qr2-for-life-sciences-organizations/): In May 2025, the International Council for Harmonisation (ICH) released the draft M4Q(R2) guideline, reshaping the regulatory landscape for pharmaceutical quality documentation. This update to the Common Technical Document (CTD) introduces a data-centric, lifecycle-oriented framework for Modules 2 and 3—enhancing clarity, digital readiness, and harmonization across major regulatory jurisdictions including the US (FDA), EU (EMA), Japan (PMDA), Canada (Health Canada), China (NMPA), Brazil (ANVISA), and more.
- [Evaluating the Global Business Impact of U.S. Restrictions on Cross-Border Data Access](https://www.freyrregintel.com/policy-perspective/evaluating-the-global-business-impact-of-u-s-restrictions-on-cross-border-data-access/): In 2025, the United States implemented 28 CFR Part 202, a landmark regulation restricting cross-border access to sensitive personal and government-related data by foreign entities, particularly those associated with China, Russia, Iran, North Korea, Cuba, and Venezuela. This rule profoundly impacts global clinical research, biotechnology, and digital health companies operating or collaborating internationally.

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