To implement the NMPA Opinions on Reform and Improvement of the Review and Approval Management System of Radioactive Pharmaceuticals, encourage drug control institutions with the ability and conditions to carry out the construction of technetium-labeled and positron radioactive pharmaceuticals testing capacity, and increase the number of qualified control institutions, the NMPA organized to formulate the Procedures for Assessment of Drug Control Institutions of Technetium-Labeled and Positron Radioactive Pharmaceuticals, which are hereby issued and shall come into force as of the date of issuance. National Institutes for Food and Drug Control shall, as per its duties, guide the construction of relevant control institutions.

It is hereby announced.

Annex: Procedures for Assessment of Drug Control Institutions of Technetium-Labeled and Positron Radioactive Pharmaceuticals by NMPA

National Medical Products Administration

March 7, 2024