Korea Drug Master File (DMF) Registration

To learn more about how we can help you obtain a DMF in Korea, please contact us.

According to the Korean MFDS, all APIs used for medicinal products that require pharmaceutical equivalence should be registered as DMFs in Korea. For the DMF submission, the application cover page, and QOS (Module 2) should be prepared in Korean, but supporting documents like CTD or GMP information can be in English. The process of submitting a DMF application in Korea and getting an approval number will take about 9 months, and the application must be submitted by a Korean local agent. Besides holding your DMF license in Korea, the local agent will also provide lifecycle management every year, including submitting an annual report, handling minor changes to your DMF, issuing LOAs, etc. Outlined below is all the information required for DMF application in Korea.

  1. Application form and checklist for submission data
  2. Data on the facilities required for Manufacturing and Quality Control
  3. Physical and chemical characteristics and stability
  4. Data on the manufacturing processes, packaging, containers, cautions in handling, etc.
  5. Data on batch analysis for drug substances, analytical procedures, solvents used, etc.
  6. Test sample for QC
  7. Registration of foreign manufacturing site for DMF
  8. GMP Evaluation

PBM can help you obtain a DMF in Korea by offering the following services:

A. Korean MFDS approval of your DMF

  1. Preparation of DMF documents
  • Define the regulatory process and identify specific requirements for obtaining KDMF registration
  • File the KDMF application (Korean) in accordance with local requirements and Prepare the application package under the web-based MFDS system
  • Communication with the Client to secure the required documents based on local regulation
  1. Follow-up MFDS review process
  • Contact the MFDS reviewers to explain or summarize the application
  • Follow-up with the MFDS/Client about the restricted parts
  • Communicate with the Client on the status of the review
  1. Prepare response documents
  • Receive the MFDS letter to request supplementation documents and communicate with the MFDS to identify the requirements
  • Communicate the additional documents or information with the Client
  • Prepare drafted responses and provide them to the Client for review and feedback
  • Submit final responses to MFDS on an agreement in writing from the Client
  1. MFDS follow-up and get the DMF certificate
  • Perform administrative processes to secure the original copy of the certificate.
  • Maintain files containing all correspondences with MFDS and provide the Client with copies of such correspondences in a timely manner

B. Local agent and ICC services

C. Assist the Client with the MFDS’s on-site inspection of the Client (if required):

An on-site inspection can be exempted if the manufacturer has experienced site inspection by the MFDS within 3 years (sterile substance) or 5 years (non-sterile substance) from the last day of inspection to the day of KDMF submission.

To learn more about how we can help you obtain a DMF in Korea, please contact us.

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.

Source used in the article: https://www.mfds.go.kr/eng/index.do