Implementation of periodic benefit risk evaluation reports in China

doi:10.19803/j.1672-8629.20230579

Abstract

Abstract: Objective To elaborate on the revision of PSUR in the Adverse Drug Reaction Reporting and Monitoring Management(Order 81) in combination with the current regulation of drugs in China. Methods The revision and implementation of the ICH E2C guideline system and related requirements in China were introduced. The status quo, problems and challenges related to the transformation and implementation of ICH E2C were outlined before recommendations were offered. Results Compared with PSUR, PBRER was more comprehensive and detailed, which could better reflect the overall situation of product benefits and risks. However, the adoption of PBRER also faced many challenges, such as a lack of knowledge of PBRER on the part of drug marketing authorization holders, the need for more professional participation in PBRER writing, and the difficulty in obtaining complete data for mature products. Conclusion The full adoption of PBRER can promote the accountability of holders and help the national and provincial adverse drug reaction monitoring agencies to supervise holders. It is recommended that PBRER be fully adopted following the revision of Order 81.

Key words: ICH, E2C, PSUR, PBRER, Adverse Drug Reaction Reporting and Monitoring Management, supervision, adverse drug reactions, marketing authorization holder

CLC Number:

R951
R994.11

TIAN Chunhua, WU Guizhi. Implementation of periodic benefit risk evaluation reports in China[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1382-1384.

References

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