Drug Evaluation Committee Briefing on the Revised Pharmaceuticals and Medical Devices Act and Online Submission of Notification of Clinical Trials to be held on February 6, 2023
Electronic Standard for Medical Information Expert Committee
The materials and recording of the "Information Meeting on the Revised Pharmaceuticals and Medical Devices Act and Online Submission of Notification of Clinical Trials" held on February 6, 2023 are now available.
This briefing session was held for pharmaceutical companies, CROs, system vendors, etc., to explain the handling of "information on clinical trial notification to be referenced" in clinical trial notification, additional explanatory items in the revised Pharmaceuticals and Medical Devices Act-related notification, and points to note in the handling of notification of clinical trial plan, etc. (online submission using the electronic data system for application).
We hope that this briefing will be of some help to you in your business operations.
- Handling of Clinical Trial Notification Information Referenced in Notification of Clinical Trial Plan for Drugs (1.21MB)
- Additional Explanatory Notes on Notification Related to the Revised Pharmaceutical Affairs Law (1.74MB)
- Points to keep in mind regarding the handling of notification of clinical trial plans, etc. (online submission using the electronic data system for application) (1.95MB)
- Submission of Clinical Trial Notification Using Application Electronic Data System - From a Company's Experience - (711KB)