In Japan, Drug Mater File (DMF), known as Master File (MF), is a system that was introduced by Pharmaceuticals and Medical Devices Agency (PMDA) to allow Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (“Products”) to voluntarily register confidential information related to the manufacturing and control of their products in Japan.
The main objective of MF registration is to protect the “know-how” and products’ confidential information that manufacturers don’t want to share with Marketing Authorization Holders (MAH).
DMF system in Japan
In Japan, the Drug Master File (DMF) is called “Master File” or “MF”. The Purpose of DMF is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products. The foreign manufacturers of APIs can apply for DMF registration.
What is the objective Purpose of DMF?
Is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products.
DMF is not a patent. The foreign manufacturers of APIs can apply for DMF registration. But the foreign manufacturers cannot apply directly to PMDA.
It is important for the DMF Holder, the in-country caretaker and related persons to understand the Japanese regulation and the guidance.
To appoint “in-country caretakers of DMF” in Japan is Essential .
DMf Registration Process:
Requirements for Lifecycle Maintenance of MF in Japan
- The ICC of MF in Japan should submit an annual report to PMDA every year after the MF first approval in Japan.
- Additionally, the ICC should submit to PMDA MF amendments, every time changes are made to the approved MF content.
- Minor changes should be notified to PMDA within 30 days of their implementation.
- Partial changes should pre-approved by PMDA before their implementation
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.