Learning Videos (Pmda Channel)
The PMDA-ATC offers you videos on introduction to the main services of PMDA and what we do to promote international regulatory harmonization.
PLAYLIST plays all the movies in the category at the external website (YouTube : Pmda Channel) .
Category
- Pharmaceuticals October 1, 2024 Updated
- Advanced Therapy Medicinal Products
- Medical Devices
- PMDA Efforts
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; https://atc-elearning.pmda.go.jp/
【Change Notice】
The URL of our website has been changed as follows.
If you have bookmarked our old site, please update the settings.
- Old (closed on March 31, 2024):https://www.pmda-atc-elearning.site/
- New (from April 1, 2024):https://atc-elearning.pmda.go.jp/
To start the training courses, please register by the following steps;
- 1) Access to the application page, please fill in the form and submit it.
- (https://www12.webcas.net/form/pub/pmda-atc/e-learning03)
- 2) After checking your application by the secretariat, PMDA-ATC will send you Login ID and password normally within 5 business days.
- 3) Your login ID will become invalid in March 2025.
Course List
- Pharmaceuticals December 5, 2024 Updated
- Advanced Therapy Medicinal Products
- Herbal Medicine
- Medical Devices
Please refer to the Frequently Asked Questions (FAQ).
Application form link for the E-learning course
Reference for the E-learning materials
ICH Guideline
The link for the ICH Guidelines
https://www.ich.org/page/ich-guidelines
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
(Note) ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
IMDRF Document
The link for the IMDRF Technical Documents
https://www.imdrf.org/documents/library?f%5B0%5D=type%3Atechnical_document
The link for the GHTF Final Documents
https://www.imdrf.org/documents/ghtf-final-documents
The link for the IMDRF Training Materials
https://www.imdrf.org/imdrf-trainings
(Note) IMDRF: International Medical Device Regulators Forum