Korea Drug Registration and DMFs for APIs, Excipients & Packaging Materials

The Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA), is the main regulatory body for drug registration and approval.

Yes, pharmaceutical and API registration is a requirement in Korea.

The Korean Pharmacopoeia (KP) is a pharmaceutical order implemented by the Korean government with regard to the improvement of public health. The KP defines the standard for quality and safety, hence drugs stated by the KP are acknowledged to be safe and efficacious in the treatment and prevention of diseases. The classifications for pharmaceuticals are as follows:

1. Drug products that do not require a safety and efficacy review – Drugs that have already been deemed safe and efficacious or are listed in the Korean and U.S. Pharmacopeia. These drugs only require a MFDS notification submission.
2. Drug products that require a safety and efficacy review, and intensive management – Drugs that require a review and approval to prevent risk factors.

1. For new drugs:
   1. Submit investigational new drug (IND) application to the MFDS.
   2. The MFDS conducts the IND application review.
   3. Submit new drug application (NDA) to the MFDS.
   4. If the MFDS does not require supplementary data, the NDA is approved.
2. Prepare the application dossier for drug approval.
3. Submit the application to MFDS Management Division for Drug Approval & Review.
4. The MFDS conducts an initial assessment of the application, generates a report outlining the application dossier, and submits it to the MFDS Drug & Evaluation Department.
5. The Drug & Evaluation department conducts a review of the following, including: results of the initial assessment, technology, safety & efficacy data, product standards, clinical trial data, good manufacturing practice (GMP) data, Drug Master File (DMF) data, impacts on intrinsic (genetic) factors, and extrinsic (factors) etc.
6. If no further documentation or supplementary data is required, The MFDS issues the applicant a Certificate of Approval.

The application dossier generally includes:

1. Origin or
backgrounds leading up to discovery and development.
2. Product structure (physical, chemical, biological) nature
3. Stability test data
4. Toxicity data
5. Pharmacologic effects
6. Clinical data – New products must fulfill the requirements of the MFDS New Drug Application (NDA)
7. Uses in other countries (if applicable)
8. Comparison with similar domestic products (if applicable)

In certain cases, the MFDS may request a local testing on the pharmaceutical product to evaluate ethnic sensitivity, foreign clinical data, and bridging data. Example tests include “Bridging Studies” (trials conducted on local Koreans). Clinical studies are required for certain types of drugs (data must fulfill NDA requirements) and must be conducted in accordance with Korean Good Clinical Practice (KGCP).

1. Drug Master File (DMF) preparation.
   The MFDS requires registration of certain substances, which are subject to DMF registration. A DMF will often contain confidential information on facilities, materials, processes, and packaging. By submitting a DMF to the MFDS, the registered manufacturer can then refer importers or distributors to the registration number without disclosing confidential information to Korean business counterparts.
2. Application submission.
   Applicants who wish to register their API may submit their application via the Korea Drug Master File (KDMF). Foreign manufacturers of these drug substances or products containing these substances can submit a DMF through a Korean importer or third-party representative with a Korean address. Domestic manufacturers can submit a DMF to the MFDS directly.
3. Once a DMF is submitted, the MFDS will review the documents and conduct a facility inspection.
   Most applications will need to undergo a facility inspection prior to receiving approval.
4. Once the application is approved, the MFDS will send a letter of acceptance and publicize the names of the DMF sponsors and registered substances.
   The timeframe is approximately 5-6 months, however, can extend to 8-9 months depending on the current capacity of the MFDS.