NMPA Released Five Informatization Standards Including the Basic Data Set for Traceability of Drug Marketing Authorization Holders and Manufacturers
To implement the provisions of the Drug Administration Law of the People's Republic of China, in accordance with the requirements of the Guiding Opinions of the China National Drug Administration on the Construction of Drug Information Traceability System (CNDA Department of Drug Supervision [2018] No. 35) and other documents, NMPA organized the formulation of the Basic Data Sets for Traceability of Drug Marketing Authorization Holders and Manufacturers, Basic Data Sets for Traceability of Drug Distributors, Basic Data Sets for Traceability of Drug Using Units, Basic Data Sets for Traceable Drugs for Consumers, and Basic Technical Requirements for Traceability Data Exchange of Drugs, which were issued on March 11, 2020, and effective as of the issuing date.