National Medical Products Administration issued the "Drug Inspection Management Measures (Trial)"

National Medical Products Administration issued the "Drug Inspection Management Measures (Trial)"

Notice
In order to implement the "Drug Administration Law" and "Vaccine Administration Law", further standardize drug inspection behavior, and promote drug supervision work to adapt to the new situation as soon as possible, NMPA has organized and formulated the "Drug Inspection Management Measures (Trial)" (hereinafter referred to as the "Measures”) and will be issued on May 28. The relevant matters are notified as follows:

1. All provincial drug supervision and administration departments shall, in accordance with the requirements of these “Measures’, combine the actual conditions of their respective administrative regions, formulate detailed implementation rules, refine work requirements, organize inspections of drug production, operation and use, continue to strengthen supervision and management and perform territorial supervision responsibilities.
2.All provincial drug supervision and administration departments shall urge drug marketing license holders in their respective administrative regions to establish and improve drug quality assurance systems, strengthen drug quality management and risk prevention and control capabilities, ensure the continued legal compliance of drug production and operation, and perform the main responsibility for drug quality.
3.This "Measures" has general regulations on the inspection of vaccines and blood products. If there are special regulations for the inspection of such drugs, the regulations shall be followed.
4.This "Measures" shall come into force on the date of issuance. The former NMPA issued on April 24, 2003, the "Administrative Measures for the Certification of Pharmaceutical Business Quality Management Practices" and the "Administrative Measures for the Certification of Pharmaceutical Manufacturing Quality Management Practices" issued on August 2, 2011, were repealed at the same time.