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China On The Move: China Reprices Clinical Data (Part Two) — The Rebuilt GCP And What Must Change Before Sept. 1
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 effective date.
United States Healthcare
GT
Greenberg Traurig, LLP
Article
July 2026 Alcohol Industry Update: Federal Antitrust Developments, Tariff Changes, And Hemp Beverage Legislation
July brought several significant federal and state developments that could reshape alcohol industry competition, pricing practices, distribution structures, and cross-border trade. At the same time, Congress continues to consider sweeping legislation that would establish a comprehensive regulatory framework for hemp-derived delta-9-tetrahydrocannabinol (THC) beverages. Together, these developments highlight evolving enforcement priorities, new compliance considerations, and potential structural changes that industry participants should monitor closely.
United States Anti-trust
SR
McDermott Will & Schulte
Article
China On The Move: China Reprices Clinical Data (Part One) — A New Exclusivity Architecture Takes Effect
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 underlying obligation upon World Trade Organization (WTO) accession.
United States Healthcare
GT
Greenberg Traurig, LLP
Article
Effective Filing Date Of Provisional And Non-Provisional Application Prior Art
The Federal Circuit vacated a PTAB decision on patent obviousness, establishing that a provisional application must provide written description support for at least one published claim to qualify as prior art under its earlier filing date. This ruling clarifies the requirements for claiming priority from provisional applications and impacts how patent practitioners should approach provisional filing strategies.
United States IP
OM
Oblon, McClelland, Maier & Neustadt, L.L.P
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