Safety-Related Drug Withdrawals in China Between 1999 and 2021: A Systematic Investigation and Analysis.

INTRODUCTION

The Chinese National Medical Products Administration (NMPA) has emphasized proactive pharmacovigilance throughout the product life cycle in recent years. However, the safety-related withdrawal of drugs from the Chinese market has received less attention.

OBJECTIVES

The primary aim of the study was to investigate the context of withdrawing a drug for safety reasons in China (between 1999 and 2021).

METHODS

Withdrawn drugs were first identified from the Chinese NMPA and United States (US) Food and Drug Administration websites and the World Health Organization's (WHO's) consolidated list of products, WHO Drug Information, and WHO Pharmaceuticals Newsletter. We then searched the China National Knowledge Internet database, Chongqing VIP information database, Wanfang database, PubMed, and Google Scholar for drug withdrawal details. We used the Oxford Centre for Evidence-Based Medicine criteria to assess the levels of evidence that support withdrawing a drug.

RESULTS

A total of 30 drugs were withdrawn from the Chinese market between 1999 and 2021. The number of withdrawals increased during the stable Chinese drug surveillance period (2012-2021). Evidence from case-series or case-control studies was primarily used to determine the withdrawals of 16 drugs (53.3%). Fifteen drugs were withdrawn from the markets of China and the US, including five drugs (5/15, 33.3%) that were withdrawn in the same year in China and the US.

CONCLUSIONS

The promulgation of regulations and development of advanced passive and active systems have enhanced pharmacovigilance in China. High-quality evidence, coordination with other regulatory authorities, and communication and information sharing should be strengthened to optimize drug safety surveillance and risk management.