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
• Good Review Practice
• Projects Across Multi-Offices in PMDA
• Record of Consultations on Pharmacogenomics/Biomarkers

Post-marketing Safety

• Outline
• Safety Information
• PMDA Risk Communications
• The Yellow Letter / Blue Letter
• 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
• J-MACS
• Regulations (in Japanese)

Relief Services for Adverse Health Effects

• Outline