- List of Approved Products
- Review Reports: Drugs
- Review Reports: Medical Devices
- Package Inserts (in Japanese)
- Good Review Practice
- Projects Across Multi-Offices in PMDA
- Record of Consultations on Pharmacogenomics / Biomarkers
- Advanced Review with Electronic Data Promotion Group
- Strategy of SAKIGAKE by MHLW
- PMDA Risk Communications
- Revision of PRECAUTIONS
- The Yellow Letter / Blue Letter
- Safety Information announced by MHLW
- MHLW Pharmaceuticals and Medical Devices Safety Information
- PMDA Medical Safety Information
- PMDA Alert for Proper Use of Drugs
- Risk Management Plan (RMP)
- Other Information (in Japanese)
- MIHARI project
- Regulations (in Japanese)
PMDA publishes on its website the results of the Consultation on Pharmacogenomics/Biomarkers held with the Predictive Safety Testing Consortium (PSTC) because PSTC requested the information addressed at the consultation to be made publicly available.
The contents and results of consultations conducted by PMDA are not subject to public disclosure, in principle. However, PMDA has decided to disclose the record of the consultation in the original Japanese as well as in English translation*, considering that such disclosure will not benefit certain companies or products alone but will help future drug development as a whole.
The conclusion shown in the record reflects the current PMDA's thoughts based on the submitted documents and scientific knowledge available at the time of the consultation. Please note, therefore, that the appropriateness of such conclusion may change as additional knowledge is accumulated and science advances.
*In the event of inconsistency between the Japanese original and the translation, the former shall prevail.