Please feel free to contact us to obtain more information about Japan DMF.
Drug component manufacturers of APIs, excipients, and drug packaging materials who want to protect their intellectual property and manufacturing processes may want to pursue a Japanese Drug Master File (DMF). The “Drug Master File” (DMF) system for APIs, excipients, and drug packaging materials enables manufacturers of drug substances to voluntarily register data on the quality and manufacturing methods of their products. This registration is used as essential information during the approval process for drug products that contain these substances.
Foreign manufacturers of APIs, excipients, and drug packaging materials who want to apply for DMF registration first need to obtain foreign manufacturer accreditation (FMA). This is because the DMF registration application form requires the inclusion of the accreditation category, accreditation number, and date of accreditation for the foreign manufacturing site. Additionally, the manufacturer codes for both the foreign manufacturer and the manufacturing site must be registered beforehand. However, if the API, excipient, or drug packaging material will not be contained in a final drug product, an FMA is not required.
During the DMF registration process, an in-country caretaker, a person or entity with an address in Japan, must be appointed to take on the responsibilities related to the relevant DMF registration. Pacific Bridge Medical’s Japan office can be an in-country caretaker in Japan during the DMF registration process for your product in Japan.
After the DMF is submitted to the PMDA, the PMDA only verifies if it adheres to the proper format, including the inclusion of minimum required items in the application and the attachment of data following the CTD M3 format. This review process usually takes 3-4 months, after which a DMF number is issued. The PMDA will only evaluate the DMF in detail while reviewing the final drug product that references the DMF number.
The DMF consists of two primary parts – disclosed (open) part and restricted (closed) part. The disclosed part consists of information that will be seen by the applicant of the drug product quoting the DMF number. On the other hand, the restricted part contains information that will be protected from the applicant of the drug product.
An overview of which information should belong to the disclosed part and restricted part is shown in the chart below.
| CTD module3 | Disclosed (Open) part | Restricted (Closed) part |
| 3.2.S.1 General Information (name, manufacturer) | x | |
| 3.2.S.2 Manufacture (name, manufacturer) | ||
| 3.2.S.2.1 Manufacturer(s) (name, manufacturer) | x | |
| 3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer) | x | x |
| 3.2.S.2.3 Control of Materials (name, manufacturer) | x | |
| 3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer) | x | |
| 3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer) | x | |
| 3.2.S.2.6 Manufacturing Process Development (name, manufacturer) | x | |
| 3.2.S.3 Characterisation (name, manufacturer) | ||
| 3.2.S.3.1 Elucidation of Structure and Other Characteristics (name, manufacturer) | x | |
| 3.2.S.3.2 Impurities (name, manufacturer) | x | |
| 3.2.S.4 Control of Drug Substance (name, manufacturer) | ||
| 3.2.S.4.1 Specification (name, manufacturer) | x | |
| 3.2.S.4.2 Analytical Procedures (name, manufacturer) | x | |
| 3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer) | x | |
| 3.2.S.4.4 Batch Analyses (name, manufacturer) | x | x |
| 3.2.S.4.5 Justification of Specification (name, manufacturer) | x | x |
| 3.2.S.5 Reference Standards or Materials (name, manufacturer) | x | |
| 3.2.S.6 Container Closure System (name, manufacturer) | x | |
| 3.2.S.7 Stability (name, manufacturer) | x | |
| 3.2.S.3.2 Impurities (name, manufacturer) | x | |
| 3.2.S.4.1 Specification (name, manufacturer) | x | |
| 3.2.S.4.2 Analytical Procedures (name, manufacturer) | x | |
| 3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer) | x | |
| 3.2.S.5 Reference Standards or Materials (name, manufacturer) | x | |
| 3.2.S.6 Container Closure System (name, manufacturer) | x | |
| 3.2.S.7 Stability (name, manufacturer) | x |
* Please note that items that are noted as both restricted and disclosed are generally disclosed. However, details pertaining to the intellectual property of the MF holder might not be revealed.
Please feel free to contact us to obtain more information about Japan DMF.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.