亚洲社会药学 ›› 2026, Vol. 21 ›› Issue (2): 115-123.

• •    下一篇

Comparative Study on Regulatory Models for Drug Safety in the United States, Japan, and European Union

  

  • 出版日期:2026-06-20 发布日期:2026-06-16

Comparative Study on Regulatory Models for Drug Safety in the United States, Japan, and European Union

  • Online:2026-06-20 Published:2026-06-16

摘要:

Objective To provide reference for optimizing China’s drug regulatory model and ensuring public medication safety. Methods Literature review was used to investigate drug regulatory models in the United States, Japan, and the European Union. Then, a comparative analysis was made. Results and Conclusion The comprehensive legal frameworks, centralized regulatory authorities, specialized regulatory personnel, and multi-stakeholder regulatory structures in these countries and regions offer valuable insights for improving and advancing China’s drug supervision.

关键词: drug regulatory, regulatory model, drug safety

Abstract:

Objective To provide reference for optimizing China’s drug regulatory model and ensuring public medication safety. Methods Literature review was used to investigate drug regulatory models in the United States, Japan, and the European Union. Then, a comparative analysis was made. Results and Conclusion The comprehensive legal frameworks, centralized regulatory authorities, specialized regulatory personnel, and multi-stakeholder regulatory structures in these countries and regions offer valuable insights for improving and advancing China’s drug supervision.

Key words: drug regulatory, regulatory model, drug safety