Updates and reflections on expedited reporting of safety information during drug clinical trials

doi:10.19803/j.1672-8629.20230624

Abstract

Abstract: Objective To advance our understanding of the requirements on implementation of expedited reporting of safety information. Methods The background and changes of FAQ 2.0, including the scope, time limit, and method of expedited reporting, were interpreted and analyzed. Results and Conclusion In order to improve the quality of safety information reports, the applicant, as the main responsible person, should fulfil his responsibility, communicate willingly with all the parties involved in the clinical trial, and collect as much information as possible. The drug regulatory authority should continue to elevate the level of pharmacovigilance during the clinical trial, improve the system of standards and codes for practice, enhance the ability to assess risks, and upgrade informatization so as to protect the safety, rights and interests of the subjects.

Key words: clinical trial, regulatory authorities, drug registration, applicants, pharmacovigilance, safety, expedited reporting

CLC Number:

R951
R994.11

LIU Min, CHEN Yan, LIU Wendong, WANG Haixue. Updates and reflections on expedited reporting of safety information during drug clinical trials[J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 98-101.

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URL: https://www.zgywjj.com/EN/10.19803/j.1672-8629.20230624

https://www.zgywjj.com/EN/Y2024/V21/I1/98

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