PMDA-ATC Generic Drugs Review Seminar 2026

Click here to see the Promotion Flyer [209KB]

Introduction

The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the “PMDA-ATC Generic Drugs Review Seminar 2026,” coordinated for overseas regulatory authority officials engaged in reviews of generic new drug applications. This seminar will be held IN PERSON in Toyama prefecture, Japan, from July 14 to 17, 2026.

The seminar will cover Japanese regulations and standards of generic drugs. Lectures are delivered by PMDA and external specialists. Participants will take up case studies, discussing in small groups. As part of the program, participants will also tour multiple manufacturing sites and relative institutions.
We welcome applications from many regulatory authorities. Please note that the seminar is closed to industry and non-regulatory authorities.

All participants are invited to a symposium celebrating the 10 anniversary of the PMDA Hokuriku Branch, in the afternoon of the first day. This will provide exclusive insight into the region's pharmaceuticals, directly from its leaders.

A link for further details will be posted onto this site as they become available.

Key Seminar Objectives

Familiarize with how generic drugs are assessed in Japan
Understand how OTC drugs and quasi-drugs are assessed in Japan
Familiarize with design and evaluation of bioequivalence (BE) studies
Develop a good understanding of ICH M13A guideline

Who should apply

Regulators ONLY (beginner to intermediate level)

Regulatory officials or relevant agency/institute employees with at least 3 years of working experience in generic drugs or other pharmaceuticals review
English will be used in the lectures and discussions during the seminar. Participants need an ability to readily communicate in English.

Dates / Time

July 14 (Tuesday), 2026 : 9:30 to 13:40 JST (UTC+9)
July 15 (Wednesday), 2026 : 9:00 to 19:00 JST (UTC+9)
July 16 (Thursday), 2026 : 9:00 to 17:00 JST (UTC+9)
July 17 (Friday), 2026: 9:00 to 11:30 JST (UTC+9)

Program (subject to change)

See the attached program [171KB]

Applications

Number of participants: approx. 25
Registrations close: May 15, 2026
To apply for the seminar, please make sure to complete all necessary items on the application form, including the form with the signature by the applicant's head of the organization, before the closing date. Click the link to register: https://www16.webcas.net/form/pub/pmda-atc/gd2026
pmda-atc generic drugs review seminar 2026 application form qr code

Selection of participants will be at the discretion of PMDA.
Confirmation of registration and additional information will be sent to the invited participants after the application closing date.

Others

Materials will be provided electronically. Participants are asked to bring their own personal computers to access these materials as needed.

Fee

There is no registration fee for this seminar.

Information on travel and hotel reservation assistance will be announced to the approved participants.
International travel insurance is not covered by PMDA; PMDA strongly recommends participants to purchase a plan before departure.

Seminar Venue

Toyama Prefecture

For more information, please contact:
Secretariat, PMDA-ATC (Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs)
E-mail: PMDA-ATC[at]pmda.go.jp

Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
(Note: For security, e-mail address' @ are replaced with [at]. Please replace [at] with @ to send e-mails to us.)