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 Product Approval
• Acceptance of Medical Device Foreign Clinical Data

ICH (Japanese ICH site)

Pharmaceuticals and Medical Devices Agency

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan