How to File a Drug Master File (DMF) in Japan

In Japan, DMF applications for APIs, packaging materials and excipients should be submitted to Pharmaceuticals and Medical Devices Agency (PMDA), that is responsible for their review and approval.??

Filing a DMF for an API, or packaging materials, or excipients with PMDA in Japan is important as it allows the manufacturer to protect company's intellectual property and confidential information related to their product. ?

Key Steps in Obtaining DMF Approval in Japan

STEP 1: Assign Market Authorization Holder (MAH) in Japan. The MAH is the local representative with the necessary Licensing from the health authority in Japan. ?

• MAH Services in Japan is offered by GRP- Japan

STEP 2: Prepare the application form (Form 42) and DMF documents as per requirements.??

STEP 3: Translate all DMF documents in Japanese.?

STEP 4: Submit the application form (Form 42) and DMF documents to PMDA in a CD??

STEP 5: Receive a DMF Certificate for approved DMF from PMDA (Form 43).?

STEP 6: Publication of DMF Non-Confidential Information on PMDA Website?

Content of DMF in Japan?

• Name of the API, excipient or packaging material.?
• Name and address of manufacturer?
• Accreditation for Foreign Manufacturing site.??
• List of ingredients, including quantity, chemical structure, and general properties?
• Description of manufacturing process, process validation, process development and materials’ controls.?
• Quality control testing, analytical procedures, validation of analytical procedures, justification of specifications and excipients of human/animal origin information (if applicable)?
• Safety data?
• Non-clinical study data??
• Test methods, including impurities and description of methods for determining structure.?
• Specifications, analytical procedures, validation of these procedures, batch analyses, justification of specifications and reference standards/materials?
• Storage conditions, stability testing data, post-approval stability protocol and expiration date?
• MAH name and address?

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