Pharmaceuticals and Medical Devices Agency (PDMA) - Japan

Pharmaceuticals and Medical Devices Agency (PMDA) was formed on April 1, 2004 to provide the cGMP pharmaceutical guideline to the nation. Relief services for adverse health effects, GMP inspection of drug manufacturing facilities and post-marketing safety measures are the main services of PMDA.

Good Manufacturing Practice Updates

• GMP Compliance Inspection concerning Pharmaceuticals (including APIs) (PDF)
• Documents to be submitted to PMDA when applying for its pre-approval GMP inspection or periodic post-approval GMP inspection of drugs or quasi-drugs (PDF)
• New Application Procedure for GMP Certification between the European Union and Japan (PDF)
• Documentation Required for Periodic GMP Compliance Inspection (PDF)
• Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs (Effective on October 21, 2010) (PDF)
• Q & A (PDF)
• Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing (When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic.) (PDF)
• GQP Ministerial Ordinance (Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices) (PDF)
• GMP Ministerial Ordinance (Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs) (PDF)
• Regulations of Buildings and Facilities of Pharmacies, etc. (PDF)
• Administrative Notice of Application of PICs GMP Guide (PDF)
• Administrative Notice on Application of PICs GMP Guide (Q and A) (PDF)
• The flow of Complaints Handling (PDF)