- Home >
- Site Map
- About PMDA
- Our Philosophy
- Message from the Chief Executive
- Outline of PMDA
- Who We Are
- What We Do
- History
- Organization
- List of Executives and Directors
Profile of Services 2011-2012- Annual Reports
- Mid-term Targets/Mid-term Plan
- Services of PMDA
- Drug and Medical Device Reviews
- Outline
- Approved Products
- List of Approved Products
- Review Reports: Drugs
- Review Reports: Medical Devices
- Package Inserts (in Japanese)
- Regulations and Procedures
- Regulations and Guidance
- Ministerial Ordinances
- Notifications and Administrative Notices
- Regulatory Procedures
- Accreditation of Foreign Manufacturers
- Master File System
- GMP
- QMS
- Other Related Information
- Frequently Asked Questions (FAQ)
- Application for Approval
- ICH (Japanese ICH site)
- Good Review Practice
- Projects Across Multi-Offices in PMDA
- Record of Consultations on Pharmacogenomics/Biomarkers
- Post-marketing Safety
- Outline
- Safety Information
- 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)
- Relief Services for Adverse Health Effects
- Outline
- International Programs
- News and Reports
- PMDA International Vision - PMDA EPOCH Toward 2020
- International Strategic Plan
- Office of International Programs
- International Harmonization
- APEC LSIF RHSC (coming soon)
- China/Japan/Korea Tripartite Cooperation
- Bilateral Relations
- Publications
- International Arrangements
- Report from Washington D.C. Metro Area
