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No, no! GMP, GSP certification is going to exit the stage of history
发布者:admin  发布时间:2018-5-9 16:15:49  点击:544
On the 29 day of last month, the General Administration of food and Drug Administration issued the decision of the State Food and drug administration to amend part of the rules and regulations (hereinafter referred to as the decision). The State Council will cancel the regulations of the Standing Committee of the National People's Congress and the Standing Committee of the National People's Congress after the National People's Congress's standing committee revise the relevant laws and regulations for the certification of the quality management of drug production (GMP) and the certification of the standard for the management of the quality of drug management (GSP).
No, no! GMP, GSP certification is going to exit the stage of history
In November 29, 2017, the State Food and Drug Administration issued the decision of the State Administration of food and Drug Administration on revising some of the rules and regulations, in order to implement the requirements of the State Council to deepen the decentralization of government, the integration of management and the optimization of the service reform. The State Administration of food and Drug Administration involved the administrative examination and approval system. The regulations of the degree reform and the reform of the commercial system were cleared up. In November 21, 2017, the decision of the State Administration of food and Drug Administration (State General Administration of food and Drug Administration) on the revision of some regulations (No. thirty-seventh of the State Administration for food and Drug Administration) was carried out from the date of publication. The following questions are read as follows:
First, why should the rules be revised?
The office of the State Council on the further completion of the regulations and the clean up of standardized documents (No. 40 of State Office [2017]) and the "letter of the State Council Legal Office on doing a good job of cleaning up the laws" (the state law letter [2017] 84) requires the departments of the national affairs academy to reform the departments involved in the reform of the "administrative clothing" Regulations and normative documents are cleaned up, and the emphasis is on the relevant provisions on the reform of the administrative examination and approval system of the State Council, the reform of the commercial system, the reform of professional qualification, the reform of the investment system, the reform of the charging system, the reform of the price, the reform of the price, and the cleaning up the intermediary services of the administrative examination and approval. The relevant provisions on the inconsistent laws and administrative regulations modified by the reform are described.
In order to carry out the above requirements of the office of the State Council and the State Council, the Bureau of the State Council has carried out the reform of the "administrative clothing" reform involving the reform of the administrative clothing of the Central Committee and the State Council of the State Council since 2013. The regulations and the cleaning of the normative documents determined the management measures for the drug management license, the measures for the administration of the Internet drug information service, the measures for the supervision and management of drug production, the measures for the supervision and management of the production of medical instruments, the measures for the management of the management of medical instruments, "the import and export of protein assimilation agents and peptide hormones." The provisions of the 8 regulations, such as the measures for the management of the food production license, the measures for the management of the food production license and the measures for the management of the food management license, are amended in accordance with the provisions of the reform of the administrative examination and approval system of the State Council and the reform of the commercial system.
Two, what is the modification?
The amendment to this regulation is to amend part of the provisions of the regulation instead of a comprehensive revision.
1. in accordance with the requirements of "one certificate and one code" in the commercial system reform, the contents of the "organization code" in the 3 regulations, such as "methods of supervision and management of medical instruments", "measures for management of medical instruments", "the management measures for the import and export of protein assimilation agents and peptide hormones", are also deleted.
2. in accordance with the requirements of the reform of the "first license and post certificate" in the commercial system, the "plan for the administration of drug management license", "the management measures for the Internet drug information service", "the measures for the supervision and administration of drug production", "the approval certificate issued by the administrative department for Industry and commerce" "issued by the administrative department for Industry and commerce", "the pre approval notice of the name of the enterprise" The book is amended as "business license".
3. according to the regulations of the drug administration law, the administrative license of the drug entrustment is put down to the Provincial Bureau, and the twenty-eighth articles on the first and thirtieth articles on drug production supervision and administration are accepted and approved by the Administration for approval and approval by the Provincial Bureau, and twenty-ninth articles are deleted. The contents of the entrusted production application of some pharmaceuticals shall be accepted and approved by the provincial bureaus, so as to maintain the overall coordination of the regulations.
4. to deepen the reform of the administrative examination and approval system, to carry out the electronic approval of administrative license and to clarify the legal effect of the electronic certificate of administrative license. In the "measures for the administration of food production license", "measures for the administration of food management license", "measures for the Administration of drug management license", "supervision and management of drug production supervision", "supervision of the production supervision of medical instruments" The supplementary provisions of the 6 regulations, such as the management measures, the management measures for the management of medical instruments, and other regulations are added separately: the electronic certificates of food, medicine, medical equipment production / operation license made by the food and drug supervision and administration department and the printed food, medicine, medical equipment production / license certificate have the same legal effect.
Three is the specification of drug production quality management (GMP) certification, drug quality management standard (GSP) certification related issues.
In accordance with the request issued by the general office of the State Council of the State Administration of food and Drug Administration (State Administration of food and Drug Administration) and the requirements for the establishment of regulations and personnel (2013) 24) "two certificates and one", our bureau has actively promoted the integration of drug production administrative license and drug production quality management standard (GMP) as an administrative permit. It is possible to integrate the certification of drug administration and Drug Administration (GSP) into an administrative license.
Decision of the State Council on cancelling a number of administrative licensing matters
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