The National Medical Products Administration (NMPA) issued Announcement No. 47 of 2026 on May 15, 2026, officially implementing the "Measures for the Implementation of Drug Trial Data Protection." The announcement aims to enhance the drug trial data protection system and promote drug innovation. Effective immediately upon release, the measures provide 3 to 6 years of trial data protection for eligible drugs, such as innovative drugs, improved new drugs, and first generic drugs. During the protection period, regulatory authorities will not approve drug registration applications submitted by other applicants that rely on the protected data.
The announcement specifies application procedures for three scenarios: First, starting from the date of the announcement, drug registration applicants may apply for data protection concurrently with their registration submission. Second, for applications accepted but not yet concluded before the announcement, eligible applicants must submit their data protection applications and supporting materials to the NMPA Center for Drug Evaluation within 15 days of the announcement’s release; otherwise, the right to data protection will be forfeited. Third, applications already in the administrative approval stage but not yet approved must also be submitted within 15 days. The announcement emphasizes that for drugs meeting the criteria for data protection, the acceptance and approval of any drug registration applications relying on the protected data will be suspended until the NMPA Center for Drug Evaluation discloses the relevant data protection information. The implementation of these measures marks a significant step in aligning China’s drug intellectual property protection system with international standards. It is expected to encourage drug innovation, balance the development of innovative and generic drugs, and enhance the overall competitiveness of China’s pharmaceutical industry.
