HeyJaredChia-Feng Lu
- Indexed articles, last 90 days
- 4
- Latest publication
- Sep 16, 2026
- Outlet visibility, for natlawreview.com
- Top 1M sites
- Earliest in this view
- Sep 3, 2026
Latest articles
2 Tracks, 1 Enterprise Strategy: US National Security Policy is Changing Life Sciences Competition with China (opens the original)
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U.S. life sciences policy toward China is shifting from list-based compliance to capability control. FDA pilots, trade measures, outbound-investment rules, research-security policies, patent proposals, and the BIOSECURE Act increasingly operate as one architecture. Taken together, these programs and laws work to accelerate U.S. discovery, trials, and manufacturing while limiting channels through which capital, data, IP, and know-how might strengthen a strategic competitor. For senior leaders at
China on the Move: China Reprices Clinical Data (Part Two) — The Rebuilt GCP and What Must Change Before Sept. 1 (opens the original)
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On June 8, 2026, four central agencies jointly published a revamped Good Clinical Practice (GCP) standard, effective Sept. 1, 2026. It is materially shorter than the standard it replaces, and that compression is the point: China’s GCP now incorporates International Council for Harmonisation (ICH) E6(R3) by reference rather than restating it, and it reallocates responsibility among sponsors, service providers, investigators, and sites in ways that may require contract amendments before the effect
China on the Move: China Reprices Clinical Data (Part One) — A New Exclusivity Architecture Takes Effect (opens the original)
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On May 15, 2026, a substantial revision of China’s Implementing Regulations of the Drug Administration Law (the Regulations or Implementing Regulations) took effect, introducing, among other items, a formal data protection framework. On the same day, China’s National Medical Products Administration (NMPA) issued the Implementing Measures for Drug Trial Data Protection (the Measures), giving operational effect to the Regulations’ data-protection article for the first time since China accepted the
BIOSECURE Act Update: Court Enjoins WuXi AppTec’s 1260H Designation, but Strategic and Compliance Clocks Keep Running (opens the original)
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On June 8, 2026, the Department of War (the “Department,” also known as the Department of Defense) published an updated 1260H list of Chinese military companies (91 Fed. Reg. 35189), adding roughly 65 entities to bring the list to about 200. Three were biotechnology companies: WuXi AppTec Co., Ltd., a major contract research, development, and manufacturing Organization (CRDMO) with substantial U.S. business, together with Complete Genomics, Inc. and Novogene Company Limited — joining Beijing Gen
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