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Current Allergy and Asthma Reports
Erschienen in: Current Allergy and Asthma Reports 9/2019

01.09.2019 | Pediatric Allergy and Immunology (W Dolen, Section Editor)

Drug Safety Evaluation in China

verfasst von: Lisha Li, Jia Yin

Erschienen in: Current Allergy and Asthma Reports | Ausgabe 9/2019

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Abstract

Purpose of Review

This review aimed to introduce the regulations management and current situations of drug safety evaluation in China.

Recent Findings

The nationwide implementation of good laboratory practice and good clinical practice guarantees the quality of pre-marketing drug safety evaluation. In recent years, post-marketing drug safety monitoring is changing from passive mode to the combination of active and passive monitoring. A national adverse drug reaction monitoring sentinel alliance has been created to actively identify, report, and evaluate adverse reactions, with more than 1.4 million cases reported in 2017. But the quality of the reports is not optimal, with few reports from drug manufacturers, low rate of severe reports, and trend of lag reporting.

Summary

Drug safety evaluation in China is transitioning from passive monitoring to a combination mode. Drug pharmacovigilance is a powerful tool for active monitoring, but participation by drug manufacturers would be essential to an effective drug safety evaluation system.
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Metadaten
Titel
Drug Safety Evaluation in China
verfasst von
Lisha Li
Jia Yin
Publikationsdatum
01.09.2019
Verlag
Springer US
Erschienen in
Current Allergy and Asthma Reports / Ausgabe 9/2019
Print ISSN: 1529-7322
Elektronische ISSN: 1534-6315
DOI
https://doi.org/10.1007/s11882-019-0872-4

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