International experience and enlightenment of patient engagement in drug regulation
- VernacularTitle:患者参与药物监管的国际经验与启示
- Author:
Jingjing WU
1
,
2
;
Kaixin ZENG
1
,
2
;
Yufei YANG
1
,
2
;
Mengyan TIAN
1
;
Fangzheng DONG
1
;
Yimeng ZHANG
1
;
Jun LI
1
,
2
;
Ningying MAO
1
Author Information
1. School of International Medicine Business，China Pharmaceutical University，Nanjing 211198，China
2. Research Center of National Drug Policy & Ecosystem，China Pharmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
patient engagement;
drug regulation;
international experience;
pathway;
enlightenment
- From:
China Pharmacy
2025;36(8):908-913
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide suggestions for improving the path and system construction of patient engagement in drug regulation in China. METHODS By reviewing initiatives and experiences from the United States （U. S.）， European Union （EU）， and Japan in promoting patient engagement， this study summarizes the roles and contributions of patients in the entire drug regulatory process internationally. Combining China’s current progress and challenges in patient engagement， specific proposals are formulated to refine regulatory pathways and institutional systems. RESULTS & CONCLUSIONS With growing global emphasis on patient engagement as a regulatory strategy， countries or regions such as the U.S.， EU， and Japan have established clear policies， designated oversight agencies， and developed diversified pathways for patient engagement. Patients contribute to regulatory processes through advisory meetings， direct decision-making roles， and leveraging lived experiences and expertise to optimize drug evaluation and monitoring. In contrast， China’s patient engagement remains primarily limited to clinical value- oriented drug development， lacking formal policy guidance. It is recommended that China， based on its existing policy system， further strengthen the construction of a safeguard system for patient engagement， improve the capacity building and pathway models for patient participation in pharmaceutical regulation， and promote the continuous development of patient engagement in pharmaceutical regulation in our country.
