Drugdu.com expert's response:

I. Mandatory Core Certifications

MF (Master File) Registration

Authority: Japan PMDA / Ministry of Health, Labour and Welfare (MHLW)

Purpose: Full API technical dossier registration, linked review with Japanese pharmaceutical companies

Requirement: Must be submitted through a domestic Japanese agent; valid for 5 years

AFM (Approved Foreign Manufacturer) Designation

Basis: Japan Pharmaceutical and Medical Device Act (PMD Act)

Purpose: Legal export qualification for overseas API manufacturers

Requirement: Renewed every 5 years; export prohibited without AFM

Japan GMP Compliance (MHLW Ordinance No. 179)

Basis: ICH Q7 + Japan GMP

Method: PMDA on-site inspection

Outcome: GMP Compliance Certificate, valid for 5 years

II. Required Supporting Documents (Per Batch / Ongoing)

Japanese domestic agent (responsible for submission, communication, and handling inquiries)

GQP (Good Quality Practice) Quality Agreement (signed with Japanese MAH)

Per-batch CoC (Certificate of Compliance) — batch number / specifications / test results / expiry date

Certificate of Origin

Japanese-compliant labels / packaging

Compliance with Japanese Pharmacopoeia (JP) quality standards

III. Brief Export Process to Japan

Appoint a Japanese agent + Japanese formulation MAH

Prepare and submit MF documentation → Obtain MF number

Apply for AFM designation + undergo PMDA document review

Pass PMDA on-site GMP inspection → Obtain GMP Compliance Certificate

AFM approved + MF linked with formulation review

Regular export: each batch accompanied by CoC, Certificate of Origin, and compliant packaging

In summary: MF Registration + AFM Designation + Japan GMP + Japanese Agent + GQP Agreement + Per-batch CoC = Legal Export to Japan