Click here to see the Promotion Flyer [213KB]
Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC Pharmaceuticals Review Webinar 2025" for officials from overseas regulatory authorities who are engaged in pharmaceuticals review. This webinar will be provided by on-line live session from December 9 to 11, 2025.
The webinar will cover topics relating to regulations on biosimilars and generic drugs review, OTC drugs and quasi drugs review, design and evaluation of bioequivalence (BE) study, and outline of ICH M13A guideline. Interactive case study on generic drug review is planned.
Key Webinar Objectives
- To learn the key regulations of the review of pharmaceuticals in Japan.
- To learn review point of generic drugs, biosimilar drugs, OTC drugs and quasi drugs.
- To learn Bioequivalence (BE) guideline and BE study.
- To obtain an opportunity to discuss how to enhance regulatory system for pharmaceuticals review.
Who should apply
Regulators ONLY (Beginner to Intermediate level)
- Regulatory officials or relevant agencies/institutes employees with at least 3 years of experience in generic drugs or other pharmaceuticals review.
- English will be used in the lectures and discussions during the webinar. Participants need an ability to readily communicate in English.
Date / Time
- December 9 (Tuesday), 2025: 14:00 to 17:00 JST (UTC+9)
- December 10 (Wednesday), 2025: 14:00 to 17:20 JST (UTC+9)
- December 11 (Thursday), 2025: 14:00 to 15:50 JST (UTC+9)
Program (subject to change)
See the attached program [169KB]
Application
Number of participants: approx. 35
Close of application: October 31, 2025
To apply for the webinar, please make sure to complete all the necessary items on the application form, including the signature by the applicant's supervisor, before the closing date.
Click the link to apply: https://atcform.pmda.go.jp/servlet/front?id=82&p=1&m=1
- If applications exceed the upper limit of 35, selection of the participants will take place at the discretion of PMDA.
- Confirmation of registration and additional information will be sent to the approved participants after the closing date.
Others
All sessions will be conducted using the Cisco Webex Meeting system.
Please confirm the attached system requirements [151KB]
Fee
There is no registration fee for this webinar. Any expenses incurred with participation in the webinar will not be covered by PMDA.
Contact Us
For more information, please contact:
Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC[at]pmda.go.jp
Office of Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
(Note: For the purpose of security, @ in the e-mail addresses are replaced with [at]. Please replace [at] with @ when you send an e-mail.)