Considerations for revision of safety information in package inserts of anti-cancer drugs in post-market phase

doi:10.19803/j.1672-8629.20230609

Abstract

Abstract: Objective To outline the considerations for the revision of safety information in package inserts of anti-cancer drugs in the post-market phase so as to provide reference for marketing authorization holders (MAH). Methods Based on the revision accomplished by the Center for Drug Reevaluation (CDR) of the National Medicinal Products Administration, the purpose, reasons, evidence and principles related to revision were presented. Results and Conclusion The revision of safety information in package inserts of drugs is a multi-departmental project. CDR will continue to improve the safety information for all authorized drugs in China, including anti-cancer drugs. MAH should fulfill their responsibility to improve drug package inserts in time so as to ensure the safe use of drugs.

Key words: package insert, safety information, post-market, revision, anti-cancer drug, drug marketing authorization holder

CLC Number:

R979.1

XIONG Weiyi, REN Jingtian. Considerations for revision of safety information in package inserts of anti-cancer drugs in post-market phase[J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 94-97.

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https://www.zgywjj.com/EN/Y2024/V21/I1/94

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