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Training Materials

Learning Videos (Pmda Channel)

The PMDA-ATC offers you videos on the current topics, introduction to the main services of PMDA and what we do to promote international regulatory harmonization.

No. Category Last updated Note
1. Review 2022.12.1 added ”History of Drug Evaluation using Foreign Clinical Data in Japan”, "Why MRCT?" contents
2. Safety 2023.2.1 added Risk Minimization Activity content
3. Relief 2020.10.31 added Relief system for ADRs content
4. Medical Device New! 2023.3.1 added Third Party Certification
5. GxP 2022.10.3 added New Approach for GMP/GCTP Compliance Inspection System content
6. PMDA Efforts 2022.4.1 added CRS content, renewed International Activities content


PMDA Recommended ICH Training Materials

Training materials developed by ICH Working Groups, ICH Training Associates and external Training Providers can be found in the below Training Library.

*ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

E-learning Courses (Regulators only)

The PMDA-ATC offers you videos regarding some specialized fields in the regulator-only website.
PMDA-ATC E-learning portal;

To start the training courses, please register by the following steps;

  1. 1) Access to the application page, please fill in the form and submit it.
  2. 2) Please select the course(s) of your interest from the list.
  3. 3) After checking your application by the secretariat, PMDA-ATC will send you Login ID and password normally within 5 business days.
  4. 4) The viewing period of the course(s) is about two months. Your login ID will become invalid at the end of the following two months.*
  5. 5) A certificate of completion of the course can be issued.

* If you apply after February 1, the viewing period will end on March 31 due to the scheduled replacement of the system. Thank you for your kind understanding in advance.

Course List
No. Course Duration Last updated
1. Quality Control (Herbal Medicine) 78 min 2022.06.08
2. Medical Devices Review 107 min 2022.07.26
3. Pharmaceuticals Review 87 min 2022.10.18
4. Multi-Regional Clinical Trial (MRCT) 114 min 2022.09.22
5. Pharmacovigilance 133 min 2022.10.27

Please refer to the Frequently Asked Questions (FAQ).



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Training Materials