Comparison of the Advisory Committees for the Pharmaceutical Regulatory Authorities of the United States, the European Union and the Republic of Korea
10.24304/kjcp.2025.35.4.243
- Author:
Minseok KIM
1
;
Minseo KANG
;
Jangik I. LEE
Author Information
1. College of Pharmacy, Seoul National University, Seoul 08826, Republic of Korea
- Publication Type:Original Article
- From:Korean Journal of Clinical Pharmacy
2025;35(4):243-256
- CountryRepublic of Korea
- Language:English
-
Abstract:
Background:Regulatory agencies operate their own advisory committee with external experts to address complex scientific issues in the approval of pharmaceutical products. However, each advisory committee operates very differently. Hence, the authors per-formed a comprehensive gap analysis among the committees operated by Food and Drug Administration (FDA), European Medicines Agency (EMA) and Ministry of Food and Drug Safety (MFDS).
Methods:The regulations, guidelines, minutes and reports on advisory committees were retrieved from the websites of FDA, EMA and MFDS. A gap analysis comparing the advisory committeesof each regulatory authority was performed, including the disclosure of information and meeting procedures, and conflict-of-interest policies.
Results:Substantial differences were found among the advisory committees in the strictness of conflict-of-interests and the transparency of meeting details. Whereas FDA and EMA disclose the detailed curriculum vitae of each committee member, MFDS does only names and majors. Whereas FDA live-streams each meeting and publishes the transcript of all dialogues by each member, EMA and MFDS release only anonymized summary minutes without live broadcasts. Whereas FDA and EMA require members to disclose their financial interests, MFDS merely requires signing a statement that confirms no conflict-of-interest.
Conclusions:Compared with Advisory Committee of FDA and Scientific Committee of EMA, the Central Pharmaceutical Affairs Advisory Committee (CPAAC) of MFDS appears to require substantial improvements in the disclosure of conflict-of-interests and the transparency ofmeeting details. This gap analysis will likely serve as a basis for policy discussions to improve the credibility of CPAAC.
