Recently, the State Administration for Market Regulation announced the Measures for the Supervision and Administration of the Quality of Drug Operation and Use (hereinafter referred to as the "Administrative Measures"), which will come into force on January 1, 2024. At the same time, the "Measures for the Administration of Drug Business Licenses" (Order No. 6 of the State Food and Drug Administration) and the "Measures for the Supervision and Administration of Drug Circulation" (Order No. 26 of the State Food and Drug Administration) were abolished.
The repealed "Measures for the Administration of Drug Business Licenses" was revised once in 2017, with a total of 35 articles in the full text, focusing on the center of "drug business license", including license application, change, inspection and supervision, and the overall content of the provisions is more, and part of the content is duplicated with the provisions of the "Administrative Licensing Law", "Administrative Reconsideration Law" and other laws, and the entire management measures are somewhat lengthy. The repealed "Measures for the Supervision and Administration of Drug Circulation" mainly stipulates the operation of drug manufacturers and drug trading enterprises, and also mentions the management requirements for the purchase and storage of drugs by medical institutions, but the full text involves only 25 specific operational provisions, which are relatively simple and limited.
The "Administrative Measures" for the supervision of drugs, is roughly divided into two levels: "drug business supervision" and "drug use supervision". The content of the drug business supervision part mainly integrates the content of the "Measures for the Administration of Drug Business Licenses" and the "Measures for the Supervision and Administration of Drug Circulation". At the level of "drug use supervision", the content of Chapter 3 of the Measures for the Supervision and Administration of Drug Circulation and Chapter 2 of the Measures for the Supervision and Administration of Drugs in Medical Institutions (Trial) (Guo Shi Yao Jian An [2011] No. 442) has been integrated, and the meaning of "drug use unit" has been formally clarified for the first time, which has solved the long-standing problem of who the "drug use unit" is.
It should be noted that the "Administrative Measures" are regulations issued by the State Administration for Market Regulation, so does it mean that the drug use management of medical institutions only needs to comply with this regulation?No, in addition to the regulations of the State Administration for Market Regulation, the National Health and Construction Commission has also issued relevant rules and regulations, such as the Regulations on the Administration of Pharmaceutical Affairs in Medical Institutions (Wei Yi Zheng Fa [2011] No. 11), which medical institutions also need to abide by.
The formulation of the "Management Measures" can be traced back to the first public consultation of the "Measures for the Supervision and Administration of Drug Operation" (draft for comments) issued by the NMPA in 2019, and then in 2021, the name was changed to the "Measures for the Supervision and Administration of the Quality of Drug Operation and Use", which was officially released in September 2023, which lasted four years, during which even the "Measures for the Supervision and Administration of Drug Online Sales" were first promulgated, which can be seen in the "Management Measures" There should be considerable controversy and disagreement in the process of formulation and deliberation.
Combined with the practical experience in the field of drugs and medical treatment, the "Regulatory Measures" will be interpreted in 20 phases one by one.
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