Meet Freya
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.
At the same time, the paper examines the growing compliance challenges U.S. firms face, particularly under evolving frameworks like 28 CFR Part 202, which imposes restrictions on data flows and demands greater scrutiny of cross-border clinical data. In this context, Regulatory Intelligence (RI) emerges as a critical enabler—empowering companies to navigate shifting policies, mitigate risk, and accelerate decision-making.
Through case studies, reform highlights, and actionable recommendations, the paper outlines how U.S. and Chinese stakeholders can build resilient, regulation-aware strategies that support innovation, protect data integrity, and sustain global health impact in an increasingly complex geopolitical environment.
Reach out to us and let’s unravel your Regulatory puzzle together. Unlock regulatory solutions with our global subject matter experts and tap into a wealth of regulatory intelligence.
Speak to an Expert
