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Pharmaceutical company employees to participate in drug registration knowledge training

Release time:

2021-03-01

News from our newspaper 2# March 5, Pharmaceutical Company organized employees to participate in online training on the work requirements related to on-site verification of drug registration application in 2021 .

This training is the first training organized by the Food and Drug Examination and Inspection Center of the State Drug Administration for registered users of the window of drug registration applicants. The window of drug registration applicants is a brand-new application platform for applicants created by the State Food and Drug Administration Verification Center to speed up the informatization construction of drug and medical device review and approval, gradually realize the electronic submission and review and approval of various registration applications, and to ensure the smooth implementation of the Measures for the Administration of Drug Registration, focusing on

"serving drug registration applicants " and combining with the on-site inspection requirements of the center. At present, the window of drug registration applicants has integrated three types of inspections: drug registration and production site verification, chemical generic drug injection registration and production site verification, and consistency evaluation and development / production site verification. Other types of inspections will also be gradually integrated and continuously updated to the platform in the future.

In order to better grasp the functions and usage methods of

"window of drug registration applicants " , comprehensively and systematically understand the procedures and requirements of online submission of information before on-site verification of "drug registration application " , and improve the quality and efficiency of drug registration verification, various departments of the pharmaceutical company actively organized relevant personnel to participate in the training, for the future drug registration, on-site verification and other work to lay a good foundation. (Lv Yating

Wang Junyang)

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