Drug Evaluation Committee File Confirmation Tool for Companies Regarding Adverse Reaction Reports from Medical Institutions to JNIH (JNIH Investigation)
Electronic Information Subcommittee
February 2012
In accordance with the "Revision of the Guidelines for Reporting Adverse Reactions, Infectious Diseases, and Defects Concerning Drugs and Medical Devices from Medical Institutions, etc.", the Pharmaceuticals and Medical Devices Agency (hereinafter referred to as "NDA") will conduct investigations on reports of adverse reactions and infectious diseases from medical institutions, etc. based on Article 77-4-2, Paragraph 2 of the Pharmaceutical Affairs Law. (hereinafter referred to as "NDA") will conduct the investigation. In line with this, based on the specific handling indicated in the July 29, 2010 Office Communication "Standard Workflow for Detailed Surveillance by the Pharmaceuticals and Medical Devices Agency Regarding Reports of Adverse Reactions, etc. from Medical Institutions, etc.", information on the results of detailed surveillance by the Agency will be shared with companies in accordance with ICH E2B ( R2)/M2 compliant ICSR files have started to be provided to companies as a means of sharing information on the results of the detailed surveillance by NIH.
The Electronic Information Subcommittee (EI Subcommittee) of the Committee on Drug Evaluation of the Japan Pharmaceutical Manufacturers Association (JPMA) has created a tool that allows you to easily output the contents of the ICSR file to MS-Excel and check the data. Please read the readme file before using this tool.
Please click the button with the version of Access you are using.
A compressed file in zip format will be downloaded, so please unzip it and use it.
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