Commissioned production issued "drug production license" assessment criteria came MAH please check.

On August 21, 2020, in order to implement the relevant requirements of the new Drug Administration Law and the Measures for the Supervision and Administration of Drug Production, the drug market license holders entrusted to others to produce preparations, further promote the implementation of the drug listing license holder system, and improve the practicality and operability of on-site inspection and acceptance standards, Jiangxi Province The official website of the Drug Administration has issued a notice on the issuance of the Opinions on the Public Request for the Evaluation Standards for the Licensing of Drug Production Licenses issued by Jiangxi Province (only applicable to the application of drug market license holders entrusted to others for the production of preparations) (draft for comments), which will be available until August 28, 2020.
This is the first domestic drug market licensing holders to entrust others to produce preparations after the implementation of the Drug Administration Law on December 1, 2019 to apply for drug production license on-site inspection and acceptance guidelines, the national level has not specifically formulated the relevant acceptance standards, this acceptance standard for the domestic entrusted to others to produce preparations MAH bid drug production license on-site inspection provides a reference at the regulatory level and technical level, this paper on Jiangxi Province, "licensed drug production license evaluation standards" draft background and main content of the analysis.
, drafting background and formulating the implementation of the MAH system based on analysis is an important measure for the CPC Central Committee and the State Council to deepen the reform of the review and approval system and encourage the innovation of pharmaceutical medical devices, and it is an important part of deepening the reform of the drug regulatory system in China.
The revised Drug Administration Law, which comes into effect on December 1, 2019, establishes the implementation of the MAH system nationwide, and the revised Regulations on the Administration of Drug Registration and the Measures for the Supervision and Administration of Drug Production, which are in force on July 1, 2020, further clarify and refine the framework, scope of application, qualification requirements and legal liabilities of the MAH system; The announcement on the supervision and management measures (No. 47 of 2020), Article 7 stipulates that those approved as MAH by the form of commissioned production shall apply for a license by July 1, 2020, but entrusting the production of MAH to apply for a license belongs to the new requirements of the State Drug Administration, the national level has not specifically formulated the relevant assessment standards, Jiangxi Province Pharmaceutical Supervision Department took the lead in carrying out this work throughout the country, formulated the standards for the evaluation of the production license for the development of drugs.
2. The main contents of the evaluation criteria for the issue of "Drug Production License" preemptively look at a total of 110 evaluation criteria for the "Drug Production License" issued by MAH, which indicates the "rejection" clause 29 and the general provision 81, as shown in the following table: All the indicators of this standard The provisions of the "rejection item" are the whole clause as the "rejection item", the main contents and characteristics of the "rejection item" clause are as follows: Third, the inspection results of the assessment of Jiangxi Province, "the issue of pharmaceutical production license evaluation standards" comprehensive assessment should be based on the principle of risk assessment, comprehensive consideration of the nature of the defect, severity and the category of products assessed to assess the inspection results.
(1) If only the general defect and the rectification of the general defect proves that the holder can take effective measures to correct it, the assessment shall be "conformity";
references to the mpa.jiangxi.gov.cn/art/2020/8/21/art_35115_2739812.html.