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 |
Training materials developed by ICH Working Groups, ICH Training Associates and external Training Providers can be found in the below Training Library.
https://www.ich.org/page/training-library
*ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The PMDA-ATC offers you videos regarding some specialized fields in the regulator-only website.
PMDA-ATC E-learning portal; https://www.pmda-atc-elearning.site/
To start the training courses, please register by the following steps;
* 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.
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).