Cancel | GMP and GSP certification to prepare for joining PIC/S?

　　

 

On November 29, the CFDA official website released the interpretation of the Decision of the State Food and Drug Administration on Amending Some Regulations, and made a detailed introduction on why the regulations should be modified and what content should be modified. Among them, "explanations on issues related to GMP certification and GSP certification" have attracted much attention.
The original text mentioned that "In order to implement the requirements of the No. 46 Document of the State Council, our bureau cancelled the GMP certification and GSP certification systems in the Amendment to the Drug Administration Law (draft for approval). At present, the draft for approval has been submitted to the State Council in accordance with the procedure for consideration by the Standing Committee of the National People's Congress. In accordance with the requirements of administration according to law, the Drug Administration Law After the modification, our bureau will uniformly modify the relevant provisions of the drug regulatory regulations concerning the GMP certification and the GSP certification. "
The author thinks that in his speech at the inaugural meeting of the 11th Pharmacopoeia Committee on August 29, 2017, Comrade Bi Jingquan mentioned: "With the approval of the State Council, we have joined the International Technical Coordination Committee for Human Drug Registration (ICH), and we will try to join the International Drug Certification Cooperation Organization (PIC/S) in the next step." The layout of CFDA is worthy of careful study.

　

 

PIC/S was established on November 2, 1995. Its predecessor was the Pharmaceutical Inspection Convention (PIC), which was established in 1970. Its purpose is to implement GMP certification with unified standards. On a voluntary basis, all member countries recognize the official GMP certification report to each other, so as to reduce non-tariff trade barriers to drug circulation and save manpower, time and material costs.
PIC/S GMP is the most rigorous GMP specification in the world so far. Therefore, the implementation of PIC/S GMP can further improve drug quality and ensure drug safety.
The three cores of PIC/S are safety (strict monitoring of raw materials and production process), effectiveness (optimization and monitoring of prescription) and uniformity (official and international general certification).
Tasks of PIC/S
1. Mutual recognition of official certification results
2. Formulate unified GMP specifications l Unified GMP certification system
3. Unified training for inspection and certification personnel
4. Exchange GMP information
5. Establish mutual trust in inspection of health authorities in various countries
As an extremely important international organization in the drug field, PIC/S coordinates and unifies the GMP inspection procedures of various countries by formulating internationally accepted drug GMP guidelines, so as to promote mutual cooperation and trust among drug regulatory agencies of various countries. Joining PIC/S and improving China's drug GMP supervision level will help China's pharmaceutical enterprises connect with the international market as soon as possible and speed up the pace of drug export, which is the fundamental guarantee for China's pharmaceutical industry to enter the international market.
The author believes that the CFDA's "unified revision of the relevant provisions concerning GMP certification and GSP certification" is intended to prepare for joining PIC/S, promote China's pharmaceutical industry and integrate with the international practice, and ultimately realize the transformation from a large pharmaceutical country to a powerful pharmaceutical country.
Source: API China API