Understanding DMF and KDMF: API Registration Systems and APIXORA's Support Scope

What is a DMF?

A DMF (Drug Master File) is a file or system in which detailed technical data on an API — manufacturing method, quality specifications and test methods, stability and more — is submitted to a regulator. A finished-product company can have this data referenced in its marketing authorization review without receiving the manufacturer's confidential information directly.

A DMF therefore protects the manufacturer's technical know-how while providing the quality evidence for the API that a finished-product authorization requires.

Regional systems: US DMF, CEP and KDMF

Systems with the same purpose differ in name and method by region. Which regional registrations or certificates a supplier holds is an important criterion when comparing proposals.

• US DMF — submitted to the U.S. FDA; APIs mostly fall under Type II. The FDA does not approve a DMF on its own but reviews it when assessing an application that references it.
• CEP — a certificate issued by the EDQM confirming suitability to the European Pharmacopoeia monographs.
• KDMF — Korea's system for registering API manufacturing and quality data with the Ministry of Food and Drug Safety (MFDS).

What is a KDMF?

A KDMF (Korea Drug Master File) is Korea's system for registering data on the manufacture and quality of an API with the MFDS. The substances subject to registration and the scope of required data follow the relevant laws and MFDS notices, so always check the latest notice to see whether a substance is covered.

Using an overseas manufacturer's API in a Korean finished product requires collaboration: the manufacturer provides the technical data and an applicant on the Korean side carries out the registration procedure.

Documents typically prepared

KDMF preparation generally needs the manufacturing process, quality specifications and test methods, impurity control, stability studies and GMP evidence for the manufacturing site. The exact list and format depend on the substance and the current regulations.

• Manufacturing process and process control data
• Quality specifications, test methods and certificates of analysis (CoA)
• Impurity profile
• Stability data
• GMP evidence (GMP certificate, WC, CoPP and so on)

Linked review and deficiency requests

In Korea, API registration data is reviewed together with the authorization or variation application of the finished product that uses the API. If the MFDS raises a deficiency request during review, the Korean applicant must answer it with data and responses from the manufacturer.

When communication between the manufacturer and the Korean pharmaceutical company slows down because of language, time-zone or data-security issues, the whole review schedule can slip, so questions and answers need to be managed systematically.

APIXORA's KDMF support scope

APIXORA supports the following KDMF-related work between overseas manufacturers and Korean pharmaceutical companies. The operations team manages progress per deal.

• Support for reviewing regulatory documents such as DMF, GMP, WC, CoPP and manufacturing process data
• Support for preparing KDMF registration documents and exchanging documents
• Coordination of manufacturer–pharmaceutical company responses in linked review and to MFDS deficiency requests
• Management of regulatory and quality questions between the buyer and the manufacturer
• Tracking of the progress and changes of regulatory documents

Where DMF information is used on the platform

When writing an RFQ, buyers can select the 'DMF / Registration' group under required documents to request data from suppliers in advance. Suppliers show a DMF status of 'Registered', 'Under Preparation', 'Available for Registration' or 'Not Available' on products and proposals, and list certificates such as US DMF, KDMF(MFDS) and CEP.

The party that files the registration and the review outcome follow the procedures of the applicant and the MFDS; APIXORA helps with data preparation and communication along the way.

Checklist before selecting a supplier

For products that need a KDMF, checking the following at the quotation-comparison stage keeps the later schedule stable.

• DMF status in the proposal (Registered, Under Preparation, Available for Registration, Not Available)
• Certificates held (GMP, CEP, US DMF, WC, CoPP and so on) and their validity
• Willingness and timeline to provide the technical data needed for KDMF registration
• Contact person and communication channel for answering deficiency requests