FDA-MEDWatch Program Visit
10.3820/jjpe1996.1.131
- VernacularTitle:FDA-MEDWatch訪問記
- Author:
Kiichiro TSUTANI
;
Motoko WATANABE
;
Reiji TEZUKA
;
Yasuo SAKURAI
;
Takeshi SANO
- Publication Type:Journal Article
- Keywords:
FDA;
MEDWatch;
adverse event;
ICH
- From:Japanese Journal of Pharmacoepidemiology
1996;1(2):131-140
- CountryJapan
- Language:Japanese
-
Abstract:
Objective : To get first-hand information on and understand MEDWatch, a newly created program of the US FDA, on safety information reporting and management.
Design and Method : Through a visit to the FDA office by Japanese members of the ICH M1 (Medical Terminology) Expert Working Group (EWG) and other concerned experts, and discussion with relevant FDA staffs.
Results and Conclusion : (1) The MEDWatch program was introduced in June 1993, to accelerate the spontaneous reporting of adverse events (AE) to FDA by developing a single Adverse Event Reporting Form, i.e., FDA 3500, for (1) drugs, (2) biologics (except vaccine), (3) medical devices, (4) food, and (5) veterinary medicines; (2) Five responsible sectors in FDA have been working together to develop a smooth flow of information from health care professionals and industries; (3) The remarkable result from the development of this new program is the increased reporting of serious AE; (4) Much efforts have been exerted by FDA on the education of health professionals through various health societies and through publications; (5) Some of the issues which remain unresolved include database integration of NDA and PMS information; (6) Advocacy of the AE concept and importance of reporting thereof by health care professionals and the use of simple, easy-to-fill-out form is recommended in Japan.
