AI x Regulatory Affairs in Japan: What’s 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.

According to us, it is a full-scale modernization aimed at global harmonization, digitization, and data-driven decision-making. The question RA teams now face is: Are we equipped for this new era of regulatory agility?

 Japan’s Regulatory Modernization in 2025: A Clear Directive

Historically, Japan’s regulatory systems have been document-heavy, siloed, and language-restricted requiring specialists to manually extract intelligence from complex Japanese-language guidance. But as Japan aligns with international regulatory practices, this model is being swiftly retired.

Here are four major shifts that are defining 2025:

• English-Language Submissions: As of September 2024, companies without a Japanese affiliate can now file New Drug Applications (NDAs) entirely in English after a prior consultation with PMDA.
• Global Outreach via PMDA: Japan has established PMDA offices overseas, starting in Washington D.C., to support multinational sponsors and promote collaborative review pathways.
• Real-World Data (RWD) Acceptance: PMDA is increasingly integrating RWD and real-world evidence (RWE) in regulatory decisions, a move that mirrors EMA and FDA approaches.
• Mandatory HFE/UE Standard (JIS T 62366-1:2022): From April 2024, all medical devices must comply with Japan’s updated Human Factors and Usability Engineering requirements.

These initiatives reflect Japan’s serious commitment to advancing regulatory science while protecting public health.

 How AI is Modernizing Regulatory Operations

AI is everywhere, and the regulatory function is no exception. For Japan’s RA teams, AI tools are solving two persistent challenges: volume and velocity. Platforms like Freya.Intelligence help transform static compliance processes into smart, real-time regulatory ecosystems.

Here’s how RA teams are applying AI today:

• Tracking PMDA/MHLW changes in real-time using automated feeds
• Classifying changes based on impact, product class, and region
• Forecasting regulatory risk using predictive analytics
• Streamlining submissions and responses across functional teams

Comparative Snapshot: Traditional vs Freya-Enabled RA

According to Freyr’s internal performance benchmarks:

• Clients have reported up to 40% reduction in time spent on regulatory tracking.
• RA teams achieve 2x faster responsiveness to changes from PMDA, EMA, and FDA.

In a landscape where delay equals lost opportunity, these efficiencies directly impact competitiveness.

 Region-Specific Pressures Facing RA Teams in Japan

Even as regulations become more globally aligned, the Japanese market retains distinct expectations. That’s where AI-enabled tools tailored to Japan’s compliance environment add significant value.

1. Multilingual Localization, Without Duplication
   Despite English-language submission flexibility, operational documents must still comply with local language requirements. Freya.Intelligence ensures full localization while maintaining global consistency.
2. Seamless Cross-Functional Compliance
   RA, Quality, and Safety teams in Japan often operate in parallel. Freya bridges these silos, offering a shared view of regulations and timelines for better alignment.
3. PMDA Audit Preparedness
   Freya’s timeline-based audit logs and compliance scoring help organizations stay inspection-ready as PMDA ramps up post-market surveillance.
4. RWD-Integrated Risk Planning
   Freya supports strategic RWD use across the regulatory lifecycle, helping RA teams meet PMDA’s expectations for data-driven decision-making.

 Why Freya.Intelligence is Built for Japan’s RA Needs

Freya.Intelligence has been purpose-designed for highly regulated, multilingual, and documentation-heavy environments.

Key features include:

• Ask Freya (our AI-powered chatbot) in the language of your choice
• Interact with ease with complex and lengthy regulatory documents
• Multilingual dashboards with Japanese-English toggles
• PMDA, MHLW and other updates delivered right into your inbox
• Workflow and impact assessment tools for better collaboration and tracking

With data sourced from over 200+ global markets, Freya centralizes intelligence across all your regional and international operations.

 Conslusion: From Reactive to Resilient

In 2025, the success of regulatory affairs will not be measured by how well you respond to change—but by how effectively you anticipate it.

MHLW, PMDA, and global authorities are moving toward a future that prioritizes transparency, digital integration, and strategic foresight. Freya.Intelligence will thus be an important strategic innovation partner in this transition.

If your RA team is aiming to:

• Strengthen compliance oversight in Japan
• Accelerate audit readiness and reduce reporting lag
• Gain full visibility into regulatory risks across markets

📅 Book a demo today or sign up for a 14-day free trial. See how Freya.Intelligence can future proof your regulatory strategy.

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