Drug Evaluation Committee Guidance for preparation of electronic reporting of adverse drug reactions and infectious disease cases -E2B(R3) compliant- (2022 edition, commentary version)
Clinical Evaluation Subcommittee Pharmacovigilance Subcommittee Electronic Information Subcommittee
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 to Drugs and Infectious Diseases - E2B/M2 Compliance -" for the smooth handling of adverse drug reaction reports by member companies. However, 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 at the same time. In addition, 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 between the publication of the 2008 guide and the previous version.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Pharmacovigilance Subcommittee Continuing Issues Response Team 2
Clinical Evaluation Subcommittee Continuing Issues Response Team 4
Electronic Information Subcommittee Task Force 2-1
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