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- Outline
- Approved Products
- List of Approved Products
- Review Reports: Drugs
- Review Reports: Medical Devices
- Package Inserts (in Japanese)
- Regulations and Procedures
- Good Review Practice
- Projects Across Multi-Offices in PMDA
- Record of Consultations on Pharmacogenomics/ Biomarkers
- Outline
- Safety Information
- PMDA Risk Communications
- Safety Information announced by MHLW
- MHLW Pharmaceuticals and Medical Devices Safety Information
- PMDA Medical Safety Information
- PMDA Request for Proper Use of Drugs
- Other Information (in Japanese)
- MIHARI project
- Regulations (in Japanese)
- Outline
- We offer face-to-face consultation services (such as clinical trial consultation, etc.) providing advices on application materials, etc. before the clinical trial stage
- We conduct GCP / GLP/ GPSP inspections and conformity audits on dossiers submitted as NDA, etc. to ensure ethical and scientific credibility of studies and documents
- We conduct approval reviews as to whether quality, efficacy and safety of the applied products meet latest scientific and technology standards
- We conduct GMP / QMS inspections to determine whether the manufacturers have sufficient capabilities of manufacturing their products with acceptable quality.
For further information