Center for Drug Evaluation of NMPA Announced on Issuing the Administrative easures for Communication of Drug R&D and

Center for Drug Evaluation of NMPA Announced on Issuing the Administrative easures for Communication of Drug R&D and Technical Review 

Pursuant to the Announcement of NMPA on Issues Pertaining to Implementing the Provisions for Drug Registration and the deployment of NMPA, to promote the drafting and formulation of related supporting normative documents and technical guidelines, the Center for Drug Evaluation organized the revision of the Administrative Measures for Communication To implement the newly formulated Vaccine Administration Law and the newly revised Drug Administration Law, and reinforce the supervision and administration of the lot release of biological products, NMPA drafted the Provisions for the Lot Release of Biological Products (hereinafter referred to as the Provisions ). The Provisions has been adopted upon deliberation at the 11th Executive Meeting of the State Administration for Market Regulation on November 19, 2020, and shall go into effect as of March 1, 2021. Vaccines are of great significance to people's health, public health safety and national security. General Secretary Xi Jinping requires to improve China's vaccine administration system and resolutely hold on to the bottom line of safety. During the revision process of the Provisions,drawing on the advanced experience of foreign lot release administration, the State Administration for Market Regulation and the NMPA resolutely implemented the “Four Strictest” requirements of the Party Central Committee and the State Council on the drug safety of vaccines, elaborated the of Drug R&D and Technical Review, which has, as per the requirements of the Notice of the NMPA Comprehensive Department on Issuing the Release  rocedures for Pharmaceutical Technical Guidelines, been released with NMPA's examination and approval for implementation as from December 10, 2020.