Drug Evaluation Committee The Japan Pharmaceutical Manufacturers Association (JPMA)'s "Explanatory Material for New Guidelines for the Description of Attached Documents of Ethical Drugs".
Pharmacovigilance Subcommittee
February 2019
The Drug Evaluation Committee PV Subcommittee Continuing Issues Team 4 has prepared an explanatory document with the cooperation of the PMDA Drug Safety Measures Divisions 1 and 2 to help deepen understanding of the new guideline both internally and externally. This document introduces the main revisions of the new guideline and the image of the attached document based on the new guideline.
We hope you will find it useful when explaining the new guideline to internal and external parties.
The material has been updated based on information as of February 5, 2019. Please note that the contents may be subject to change due to notices, etc. to be issued in the future.
New Guideline for the Description of Attachments to Ethical Drugs Explanatory Material (1.4MB)