內容目錄
Notice on optimizing procedures to improve the quality and efficiency of drug and medical device registration
In order to further promote the reform of “decentralization, regulation and service” and improve the efficiency of administrative examination and approval, according to the “Administrative Measures for Drug Registration” of the State Food and Drug Administration, “Administrative Measures for Registration and Filing of Medical Devices”, “Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents” and other relevant regulations, combined with the actual situation of our province, are hereby notified of matters related to optimizing the registration procedures for drugs and medical devices as follows:
1. Simplify the sampling procedures for drug registration inspection. The process of signing and transferring the registration management office of the provincial bureau is reduced. The applicant directly submits a sample application for drug registration inspection to the provincial bureau inspection center. The provincial bureau inspection center organizes the sampling and seals it up. The data and reference materials are sent to the corresponding drug testing institutions.
2. Reduce the sampling link of in vitro diagnostic reagent registration test. In accordance with the “Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents”, the provincial bureau will no longer organize the implementation of in vitro diagnostic reagent registration inspection and sampling. The inspection report submitted for registration can be a self-inspection report issued by the applicant, or an inspection report issued by a qualified medical device inspection agency.
Third, optimize the verification process of the third-class medical device registration quality management system. Adjust and optimize work procedures, and carry out data review and on-site verification in combination. After the provincial bureau received the system verification notice from the National Bureau of Medical Device Technology Review Center, the provincial bureau inspection center simultaneously carried out data review and on-site inspection, and designated a special person to connect with applicants to improve work quality and efficiency. According to the specific situation of the applicant, the supervision and inspection situation, the production conditions and process comparison between the products applied for registration and the products that have passed the inspection in the past, etc., the content of the on-site inspection shall be arranged as appropriate to avoid repeated inspections.
4. Consolidation of drug registration inspection items. The provincial bureau organizes the daily supervision of drug non-clinical safety evaluation research institutions and drug clinical trial institutions. It can be carried out in combination with drug registration verification, and an inspection team can be sent to implement it simultaneously to avoid repeated inspections and improve the efficiency of daily supervision.
It is hereby notified.
Hubei Drug Administration
March 8, 2022
Source: Hubei Drug Administration
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