Jiangsu uses the "four most stringent" standard regulatory collection of drugs to guard the safety bottom line of the people for medication

The purchasing volume procurement of drugs has attracted much attention. The reporter learned from the Jiangsu Provincial Drug Administration that in order to ensure the quality and safety of drugs in the collection, the Jiangsu Provincial Drug Administration included the selection of drug quality supervision in the collection The "four strictests" requirements of drug safety, implement the quality subject responsibility of the selection of drug listing permits, implement two full coverage of supervision and inspection and product random inspection, conscientiously organize special inspections and accurate assistance efficient.

According to laws and regulations such as the "Drug Administration Law", "Measures for the Supervision and Management of Drug Production", and "Regulations on the Management of the annual Report of Drugs", the provincial bureau has newly revised the "Jiangsu Pharmaceutical Listing Permit (Drug Production Enterprise) Drug Quality and Safety Anthology List List of List of Responsibility List. With negative list (2022 edition) ", a notice on the development of 2022 drug production quality and safety self -correction work" was released. The deployment of enterprises to carry out a new round of self -examination and self -correction, comprehensively implement the main responsibility The process continues to be legal and compliant, and effectively improves the quality of drug selection in the collection and mining to ensure the safety of public medication. According to statistics, there are currently 1-6 batches of national collective collection and other provincial-level collection of 480 companies in Jiangsu Province.

At the same time, the Provincial Bureau has formulated a special inspection plan and issued the "Notice on the Supervision of the Quality Supervision of Medicine Production in the Collection" and "Notice on the Requirements on Special Inspection of the Selection of Drug Production in the Collection". Incorporating the change of the varieties and auxiliary bags, changes in production technology, and mass changes, etc., strengthen supervision and inspection, and strengthen monitoring of adverse reactions in key varieties. At the same time, we took the initiative to strengthen contact with the provincial medical insurance department, and communicate and establish a joint supervision mechanism for the selection of drugs in the collection. In the first half of the year, the Provincial Bureau of Pharmaceutical Production Supervision Division led it, and the inspection branches coordinated the epidemic prevention and control and daily supervision and inspection. As of the end of June, a total of 64 237 products were collected and selected for the selection of drug supervision and inspection, 283 samples were sampled, and 87 batches were completed, all of which were qualified.

In addition, the reporter also learned that in order to effectively help enterprises overcome the impact of the epidemic, solve problems encountered in the production process, and ensure normal production and supply, the Provincial Bureau of Pharmaceutical Production Supervision has launched a "help enterprise to help enterprises to relieve the rescue of the enterprise in early June to help the enterprise rescue the rescue. The theme activity of precision assistance, focusing on collecting various needs and difficulties encountered in the production process of enterprises, especially the selected varieties in the collection of materials in the production process, and the research after listing after listing. Solving doubts. At present, 33 issues have been reported to the enterprise, all of which have been arranged to answer and communicate in a timely manner to effectively solve the problems encountered in the production process of the enterprise, and effectively guarantee the normal production and supply of drugs in the collection.

Correspondent Shen Yixuan

Nanjing Morning Post/Ai Nanjing reporter Qi Zaibing

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