Master File Registration
PPBIZ supports Master File (MF) applications to PMDA.
PPBIZ acts as an In-Country Caretaker (ICC) for overseas API manufacturers and handles registration applications on their behalf.
PPBIZ acts as an In-Country Caretaker (ICC) for overseas API manufacturers, and PPBIZ acts as the In-Country Caretaker for applications for AFM (Authorization of Foreign Manufacturing Companies) on behalf of overseas API manufacturers.
PPBIZ acts as the in-country caretaker (ICC) for APIs applying for MF (Manufacturing Method) and registration of their products. PPBIZ also provides support for smooth communication of information, negotiation with the authorities, and approval review of quality and other aspects.
MF registration allows for review by PMDA without disclosing intellectual property to the marketing authorization holder.
Our main services include
Services related to foreign manufacturing company accreditation (AFM)
- AFM registration ~ review by PMDA
- Prepare an AFM application form from drawings of manufacturing plants and testing facilities and a list of facilities.
- AFM application to PMDA
- Support for questions from PMDA
- Support for manufacturers and distributors
- After AFM certification
- Management of changes in AFM: Reflecting changes in address, manufacturing location, registered facilities, etc. in the certification details
- Annual inspection of AFM certification details
- Management of application data and certificates
MF application and registration related operations
- MF application - review by PMDA
- Translate necessary contents of CTD into Japanese and prepare MF application form
- Apply for MF registration to PMDA
- Management of MF registration certificate
- Respond to review inquiries from PMDA, including issuing access letters to manufacturers and distributors
- Support PMDA compliance audits as necessary
- After review by PMDA
- MF change management: Reflect changes in manufacturing methods, test methods, etc. in the MF
- Annual inspection of MF support
- Management of application data and registration certificate
In-Country Caretaker (ICC) duties
As an ICC, PPBIZ supports overseas manufacturers in the review of AFM accreditation and MF application/registration with PMDA. We also provide support in answering related questions from PMDA. We also provide post-audit maintenance management.
Support for Japan GMP
PPBIZ provides overseas manufacturers with advice and verification of compliance with Japanese GMP standards.
- Inspections based on Japan-GMP are conducted by PMDA at the time of review of pharmaceutical products using active pharmaceutical ingredients.
- Inspections are also conducted when overseas manufacturers renew their facilities, etc.
- Prepare for PMDA inspections
- Consultation on Japan-GMP