Drug supervision policy quick view of drug inspection inspection and inspection, support supervision work, stable and far away
Author:China Medical News Information Time:2022.07.28
Drug inspection and inspection runs through the entire life cycle of the drug, providing important support for the national drug supervision work, and providing important guarantees for ensuring drug safety. Recently, the National Drug Administration's inspection center issued a report on the 2021 drug inspection work, and a total of 1368 drug inspection and inspection tasks were completed throughout the year.
Among them, 1214 pharmaceutical registration verification tasks were completed, including 1066 registration and verification tasks of clinical trials and listing permit applications, and 148 tasks of the quality and efficacy of generic drugs. Through the authenticity, consistency of the application information, and the commercial production conditions of the drug listed, check the compliance and data reliability of the applicant's development process, to ensure the successful development Produce.
101 pharmaceutical supervision and inspection tasks, including 10 Chinese medicine supervision and inspection tasks, 5 chemical drug supervision and inspection tasks, vaccine inspection, blood product spot checks, and 84 tasks for other biological product inspection, and 2 anesthesia psychiatric drug management inspection tasks. Through the implementation of relevant laws and regulations on the implementation of the pharmaceutical listing license holder and the drug production enterprise, and the implementation of the quality management of drug production quality management, it promotes its continuous compliance to carry out production.
In addition, 47 permit inspection tasks have been completed, and 6 remote non -on -site inspection tasks have been completed.
Source: State Drug Administration
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