On October 8, Zhejiang Provincial Food and Drug Administration issued the Announcement on Matters Related to GMP and GSP Certification of Drugs.
According to the announcement, the Zhejiang Provincial Food and Drug Administration announced the following matters related to drug GMP and GSP certification:
From December 1, 2019, the 1. will no longer accept matters related to drug GMP and GSP certification.
2. Before December 1, 2019, in accordance with the ''Notice on the Issuance of the Measures for the Administration of the Certification of Pharmaceutical Manufacturing Quality Management Regulates'' (State Food and Drug Administration An  No. 365), pharmaceutical manufacturers that have obtained the ''Drug GMP Certificate'', their corresponding If the certificate is valid for 6 months before the expiration of the certificate (the certificate is valid before June 1, 2020), the enterprise can apply for drug GMP certification. Enterprises should be able to accept certification on-site inspection at any time after application.
3. pharmaceutical manufacturers that have obtained the "Drug GMP Certificate" and whose certificates are valid after June 1, 2020, the Zhejiang Provincial Drug Administration will no longer accept matters related to drug GMP certification from October 20, 2019. If there are major changes in the newly-built and rebuilt workshops, they can apply for certification before December 1.
4. a pharmaceutical trading enterprise that has obtained the "Drug GSP Certificate", if the certificate is valid after June 1, 2020, it will no longer accept matters related to drug GSP certification from October 20, 2019.
▍取消GMP、GSPCertification, official landing
On August 26, 2019, the amendment to the the People's Republic of China Drug Administration Law was passed by a vote. At that time, Cyberlan learned from authoritative channels-confirming the cancellation of GMP and GSP certification.
The newly revised "the People's Republic of China Drug Administration Law" will come into effect on December 1, 2019. Judging from the announcement of the Zhejiang Provincial Drug Administration, Zhejiang Province will start the first shot to cancel GMP and GSP certification. There will be more provinces to keep up with the pace, please keep a close watch.
As early as 2014, the voice of gradual decentralization and cancellation of drug GMP and GSP certification has been constantly heard. In the future, the certification system will be combined with the access standards of drug enterprises, as well as the supervision of daily production and operation, so as to reduce the examination and approval supervision and strengthen the daily supervision and inspection.
At the end of 2015, relevant officials of the former State Food and Drug Administration stated at a meeting that in accordance with the requirements of the State Council, from January 1, 2016, the General Administration will delegate all GMP certification authority to provincial bureaus. It is also clear that GMP certification will gradually merge with production license in the future.
On October 22, 2018, the draft amendment to the Drug Administration Law was first submitted to the sixth meeting of the Standing Committee of the 13th National People's Congress for deliberation. The draft amendment proposes to implement the drug marketing license holder system, delete the drug production quality management practice (GMP) certification and drug business quality management practice (GSP) certification of pharmaceutical enterprises, and change the drug clinical trial institutions from license management to record management.
Now, according to the newly revised "the People's Republic of China Drug Administration Law", GMP and GSP certification will be completely canceled before December 1, which is a perfect end to the cancellation of GMP and GSP certification.
Pharmaceutical companies should still pay attention to inspection
After the cancellation of GMP and GSP certification, does it mean that the supervision will be stricter and the flight inspection will be more frequent?
That's for sure. Although GMP and GSP certification have been canceled, pharmaceutical companies still cannot take quality lightly and should do better.
In the past, many people looked forward to the cancellation, because the vast majority of people think that the certification process is too troublesome. However, after the real cancellation of certification, will the regulatory authorities really not come to check? On the contrary, it will definitely check more and more scientifically.
On July 18, 2019, the General Office of the State Council issued the document ''Opinions on Establishing a Professional and Specialized Drug Inspector''. The document shows that professional and specialized drugs (includingMedical Devices
) Inspector meansDrugs
The regulatory authorities have determined that the personnel who conduct compliance confirmation and risk research and judgment on the management counterparts engaged in drug development, production and other places and activities in accordance with the law are an important supporting force for strengthening drug supervision and ensuring drug safety.
The purpose of establishing a team of drug inspectors is to build a professional and specialized drug inspector team system that basically meets the requirements of drug supervision, and to further improve the professional and specialized drug inspector team with full-time inspectors as the main body and part-time inspectors as supplements., To form a drug supervision and inspection work system with clear powers and responsibilities, smooth collaboration and comprehensive coverage.
Despite the cancellation of GMP and GSP certification, judging from the fact that the State Food and Drug Administration and various provinces are actively establishing a team of specialized drug inspectors, it reflects to a certain extent that it will beEnterprise
Increased intensity and frequency of daily and unannounced inspections.
GSP is the floor, is the minimum standard, is the lowest threshold, so do not need certification. GMP and GSP have also become the most basic and lowest configuration requirements for enterprises.