AFD China Newsletter - June 2026

China Introduces Protection Periods for Clinical Trial Data

China has granted a six-year protection period for clinical trial data on innovative drugs, the National Medical Products Administration (NMPA) said.

The six-year protection applies to innovative drugs and originator drugs, calculated from the date of drug registration. Improved new drugs receive four years of data protection, and first generic drugs receive three years, according to a guideline issued by the administration. Ordinary generic drugs and biosimilars are not granted data protection.

During the protection period, the administration will neither accept nor approve any marketing application filed by other applicants that relies on the protected data without the holder's consent.