The General Administration issued a document, GMP, GSP certification is completely gone

On November 29, the China Food and Drug Administration issued the "Decision of the State Food and Drug Administration on Amending Some Regulations" (hereinafter referred to as the "Decision").

The "Decision" proposes that the State Council will request the Standing Committee of the National People's Congress to revise relevant laws and regulations in accordance with legal procedures and cancel it.

▍The administrative license for the entrusted production of drugs is delegated to the provincial bureau

This amendment to the regulations is a revision of some provisions of the regulations, not a comprehensive revision. The specific amendments are as follows:

First, in accordance with the requirements of “one certificate, one code” in the reform of the commercial system, the “Measures for the Supervision and Administration of Medical Device Production”, the “Measures for the Supervision and Administration of Medical Device Operation” and the “Measures for the Administration of the Import and Export of Protein Assimilation Preparations and Peptide Hormones” were deleted. "Organization code" related content.

Second, in accordance with the requirements of the commercial system reform of "license first and then permit", the "Administrative Measures for Pharmaceutical Business Licenses", "Administrative Measures for Internet Drug Information Services", "Measures for the Supervision and Administration of Drug Production" and other three regulations "issued by the administrative department for industry and commerce" The approval certificate of the proposed enterprise” and the “pre-approval notice of the name of the proposed enterprise” are changed to “business license of the enterprise”.

Third, in accordance with the "Drug Administration Law", the administrative licensing of drug consignment production is delegated to the provincial bureau. The acceptance and approval are revised to be handled by the provincial bureau, and the content of Article 29 that the provincial bureau is responsible for the acceptance and approval of some applications for the commissioned production of drugs is deleted, so as to maintain the overall coordination of the regulations.

Fourth, in order to deepen the reform of the administrative examination and approval system, implement the electronic examination and approval of administrative licensing, and clarify the legal effect of the electronic certificate of administrative licensing, in the "Administrative Measures for Food Production Licensing", "Administrative Measures for Food Business Licensing", "Administrative Measures for Pharmaceutical Business Licensing", "Drugs" An additional article is added to the supplementary provisions of the six regulations, including the Measures for the Supervision and Administration of Production, the Measures for the Supervision and Administration of Medical Device Production, and the Measures for the Supervision and Administration of Medical Device Operation: The production/operation licenses for food, drugs, and medical devices produced by the food and drug supervision and administration department. The certificate has the same legal effect as the printed food, drug and medical device production/operating license.

▍Cancellation of GMP and GSP certification has been submitted for approval

In accordance with the requirements of the "two certificates in one" issued by the General Office of the State Council, the "Notice of the State Food and Drug Administration's Main Responsibilities, Internal Organizations and Staffing Regulations" (Guobanfa [2013] No. 24), our bureau actively promotes the integration of drugs into one. The production administrative license and the Good Manufacturing Practice (GMP) certification are integrated into one administrative license, and the pharmaceutical distribution administrative license and the Pharmaceutical Distribution Good Management Practice (GSP) certification are integrated into one administrative license.

According to the "Decision of the State Council on Cancelling a Batch of Administrative Licensing Items" (Guo Fa [2017] No. 46), for the certification of Good Manufacturing Practice (GMP) and Good Manufacturing Practice (GSP) certification, the State Council will submit a request for The Standing Committee of the National People's Congress shall revise relevant laws and regulations and cancel it.

In order to implement the requirements of Guofa No. 46, our bureau has canceled the Good Manufacturing Practice (GMP) certification and the Good Manufacturing Practice (GSP) certification system in the "Amendment to the Drug Administration Law" (draft for review).

At present, the draft for review has been submitted to the State Council and submitted to the Standing Committee of the National People's Congress for deliberation. In accordance with the requirements of administration according to law, after the revision of the "Drug Administration Law", our bureau will uniformly revise the relevant provisions of the drug regulatory regulations involving the certification of Good Manufacturing Practice (GMP) and Good Manufacturing Practice (GSP) certification.