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.