Guangming.com (Reporter Zhang Mengfan) At the press conference held by the National Health and Health Commission on July 22, Yuan Lin, director of the Drug Administration Department of the State Food and Drug Administration, said that the State Food and Drug Administration will continue to strengthen the quality supervision of the selected products, and effectively do Focus on the quality supervision of the selected drugs and medical devices, continue to urge the selected enterprises to implement the main responsibility for quality, and better protect the safety of medical devices for the general public.
First of all, the State Food and Drug Administration has specially deployed to strengthen the quality supervision of selected drugs in centralized procurement. Organize provincial drug regulatory authorities to conduct full-coverage supervision and inspection, product sampling inspection, and continuous strengthening of adverse reaction monitoring on selected drugs in centralized procurement.
Secondly, continue to strengthen the quality supervision of selected medical devices in centralized procurement. On the one hand, guide the provincial drug supervision and administration departments to supervise enterprises, strictly implement the main responsibility for product quality and safety, and carry out full-coverage inspections of selected enterprises and products for centralized procurement; In 2022, the State Food and Drug Administration will organize a full-coverage quality sampling inspection of vascular stent varieties, artificial joints and other varieties selected by the national centralized procurement. So far, the sampling results are all qualified.
Third, further urge the implementation of the main responsibility for the quality of the marketing license holder or the manufacturer, and strictly implement the requirements of GMP (Good Manufacturing Practice for Pharmaceutical Products). Specifically, the holder or the manufacturer should organize production in strict accordance with the approved standards and processes, strictly conduct the review and control of raw and auxiliary material suppliers, strictly conduct research and management on post-marketing changes of drugs, study and judge the identified risks, and timely Take effective control measures. Establish and improve an information-based traceability system to collect traceability information throughout the process.
Fourth, carry out in-depth supervision and inspection of selected drugs and medical devices in centralized procurement. In response to the violation of the drug production quality management standards by individual enterprises found in the on-site inspection, measures such as suspending the production and sales of related enterprises' products, recalling listed products, etc., are taken according to law, and coordination and cooperation are made to ensure product supply. In response to the unqualified situation of individual imported drugs found in the sampling inspection, risk control measures shall be taken in a timely manner in accordance with the law, and joint disciplinary actions shall be implemented in cooperation with the medical insurance department. In terms of the supervision of selected products for medical devices, from January to June 2022, the provincial drug administration departments will inspect 221 companies, 1,371 distribution companies, and more than 10,000 users. The inspection results show that the overall quality The operation of the management system is generally good.
Fifth, strengthen the supervision and guidance of cases and complaints and reports, and properly handle and handle complaints, reports, letters and visits, public opinions and other related case clues involving the production, circulation, and use of the selected drugs and equipment in centralized procurement. Organize the selection of typical cases of drugs and medical devices, and in the form of a compilation of typical cases, further guide the local drug regulatory authorities to strengthen the investigation and handling of cases, and actively cooperate with relevant departments to investigate and deal with violations of laws and regulations.
State Food and Drug Administration: Do a good job in quality supervision of selected drugs and medical devices in centralized procurement
2022 07/22