Heavy, the new version of the GMP guide has been revised!

On August 27th, the "Drug GMP Guide Series" revision and compilation kick-off meeting jointly sponsored by the Food and Drug Inspection Center of the State Drug Administration (hereinafter referred to as the Verification Center) and China Health Media Group China Medical Science and Technology Press Co.

With the changes in laws, regulations, technical specifications and standards, the focus of drug supervision has shifted from "compliant with drug GMP" to "continuous compliance with drug GMP" , as well as the drug marketing authorization holder system, drug traceability system, digital management, and drug safety credit The establishment of a series of systems such as supervision, credit joint disciplinary action, and drug life-cycle supervision.

Dong Jiangping, deputy director of the Food and Drug Inspection Center of the State Drug Administration, said that the drug GMP guide series has played an active role in helping manufacturers to better learn, understand, and implement drug GMP.

She said that with the National Medical Products Administration becoming a member of the ICH Management Committee, China’s NRA assessment has entered the third stage, and the application to join the PIC/S organization is fully put on the agenda.

In order to meet the needs of the domestic and international situation and the needs of enterprise development, the revision of the Pharmaceutical GMP Guidelines series has undergone adequate investigations, expert evaluations and demonstrations of pharmaceutical enterprises in the early stage

Relevant staff from the Verification Center, China Medical Science and Technology Press, and Peking University Pharmaceutical Information and Engineering Research Center and representatives of industry associations attended the main venue.