Drug Evaluation Committee Guidance for preparation of electronic adverse drug reaction and infection case reports -E2B(R3) compliant- (2022 Explanation)
Clinical Evaluation Subcommittee Pharmacovigilance Subcommittee Electronic Standard for Medical Information Expert Committee
September 2022
Since October 2003, when E2B/M2-compliant electronic reporting was implemented in Japan, we have prepared and revised the "Guide to Electronic Reporting of Adverse Reactions and Infectious Drug Reactions - E2B/M2 Compliance -" for the smooth handling of adverse drug reaction reports by our member companies. -In recent years, there has been an increase in the use of multiple drugs simultaneously for the treatment of diseases, and clinical trials using various drugs other than the study drug are being conducted simultaneously. In light of these circumstances, the Pharmaceutical Affairs Law was revised in September 2020 to require sponsors to report to the Minister of Health, Labour and Welfare adverse drug reactions from control drugs and concomitant drugs used in addition to the study drug.
This guide is a revised version of the ICH E2B (R3) guide that reflects these changes and the related notifications on adverse drug reaction reporting that have been revised since the publication of the 2008 edition of the guide.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Pharmacovigilance Subcommittee Continuing Issues Response Team 2
Clinical Evaluation Subcommittee Continuing Issues Response Team 4
Electronic Standard for Medical Information Expert Committee Task Force 2-1