Drug Evaluation Committee The "Explanatory Material for the New Guideline for the Description of Attached Documents of Ethical Drugs".
Pharmacovigilance Subcommittee
February 2019
The Drug Evaluation Committee PV Subcommittee Continuing Issues Response Team 4 has prepared an explanatory document with the cooperation of PMDA Drug Safety Measures Divisions 1 and 2 to help deepen understanding of the new guideline both internally and externally to relevant parties. 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)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables