Medicinal Products

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South Korea Drug Registration and Approval process

The global pharmaceutical market is experiencing significant growth and is projected to reach USD 352.98 billion by 2030, with a compound annual growth rate (CAGR) of 5.9% during the forecast period of 2023-2030.

South Korea Drug Registration and Approval process is becoming increasingly important as South Korea, one of the emerging global markets for pharmaceutical products, valued at $27.9 billion in 2020, is expected to grow at a CAGR of 4.4% and reach $35.1 billion by 2030.

As the demand rises, Pharmaceutical Regulatory Affairs in South Korea plays a crucial role in navigating compliance requirements and ensuring the successful entry of products into this expanding market. Regulatory professionals must understand the complex landscape of the South Korea Drug Registration Process to ensure compliance and market access.

In South Korea, manufacturers must obtain approval from the Ministry of Food and Drug Safety (MFDS Korea), which oversees all aspects of drug product registration. The MFDS registration process requires attention to safety, efficacy, and manufacturing compliance.

The growth of the Korean pharmaceutical industry has been driven by leading Korean companies releasing new global drugs and achieving technology exports. Pharmaceutical majors in Korea are striving to enhance competitiveness to the level of advanced countries by obtaining MFDS approval for drug product registration in South Korea and launching new drugs developed in Korea in overseas markets through the continuous expansion of R&D investments.

Drug Classification

For the Drug Registration Process in South Korea, it is crucial to identify the category of the product, as the Regulatory approval process depends on that. Based on MFDS Korea, often referred to as the Korea Food and Drug Administration (KFDA), drugs are classified as follows:

  • New Drug: A drug product that is a new chemical entity (NCE) of which a chemical structure or essential composition is completely new compared to previously approved drugs in Korea, which are regulated under the Pharmaceutical Affair Act, or is a combination preparation which has an NCE as an effective ingredient.
  • Drug subject to data submission: A drug product that is not classified as a new drug but requires the safety and efficacy review to be carried out in accordance with MFDS regulations.
  • Generic Drug: A drug product which is equivalent to a new drug (reference drug) in terms of active ingredient, dosage form, and strength.

Freyr experts will help you with the Drug Registration and Approval Process in South Korea by determining the proper category, related Regulatory drug registration process in South Korea, and overall medicinal products regulatory support in the region. We also support early-stage MFDS consultation and decision-making.

By leveraging drug classification systems, Freyr can help you take your product global while ensuring compliance with MFDS clinical research and registration guidelines.

South Korea Drug Registration and Approval process 

Based on the MFDS regulations, the registration of a drug in South Korea depends on the Regulatory classification of the drug product. The South Korea Drug Registration and Approval process looks like this:

For IND Application of new drug candidates: 

  • Submit an Investigational New Drug (IND) application to the MFDS.
  • The MFDS conducts the IND application review.
  • MFDS may request supplement data if necessary.
  • IND Application is approved by MFDS.

For New Drugs Application: 

  • Prepare the NDA application dossier based on MFDS regulations – the dossier must align with the MFDS registration requirements, covering data on safety, efficacy, and GMP compliance.
  • Submit the NDA application to the MFDS portal site for drug registration in South Korea.
  • The MFDS conducts a review of NDA application dossiers in each review department, evaluating sections such as “Safety & Efficacy”, “CMC (test method & specification)”, and “GMP”.
  • Each review department can request supplement data if the dossier does not meet MFDS clinical trial or approval requirements after the first review.
  • The GMP review department can conduct an MFDS inspection of the manufacturing sites of drug products and drug substances in foreign countries. The schedule of site inspection will be arranged between MFDS and the manufacturing site. The GMP review department can also request supplement data after the site inspection.
  • If no further documentation or supplementary data is required, the MFDS issues the applicant with a product license of approval, completing the MFDS approval process.

Important Validities 

The Ministry of Food and Drug Safety (MFDS) issues the product license, which is valid for five (05) years and must be renewed based on a re-evaluation of the benefit/risk balance by the competent regulatory authority. The renewal process is part of the larger MFDS post-approval change management framework.

Freyr supports you with post-approval life cycle management, including product renewals, and provides comprehensive guidance on Pharmaceutical Regulatory Affairs in South Korea. Our team is here to assist with the entire South Korea Drug Approval Process and ensure smooth navigation through the drug registration process in South Korea.

South Korea Drug Registration and Approvals - Freyr Expertise

  • Regulatory Intelligence Support
  • Regulatory Due Diligence Support
  • South Korea Drug Registration and Approval Process
  • Foreign Manufacturing Registration (FMR)
  • Marketing Authorization Holder (MAH) / In-country Caretaking
  • Active Pharmaceutical Ingredient DMF Filing Services
  • Good Manufacturing Practices (GMP) Conformity
  • Submission Management to Health Authorities (e.g., MFDS)
  • Providing Translation Services
  • Data Reliability Inspection
  • Planning Timely QMS Inspections
  • Reimbursement Application Submission
  • Labeling and Artwork Support
  • Distributor Identification and Qualification
  • Guidance on product registration in South Korea

 

Conclusion

Successfully navigating the South Korea Drug Registration and Approval process requires a thorough understanding of MFDS guidelines, regulatory classifications, and documentation standards. With increasing global attention on the Korean pharmaceutical market, timely and compliant product registration is critical for gaining competitive advantage and market access.

Whether you're registering a new drug, generic, or submitting an IND, having the right regulatory partner ensures seamless execution across all phases. Freyr’s end-to-end support simplifies the South Korea Drug Registration and Approval process, empowering pharmaceutical companies to enter and expand in this high-potential market with confidence.

Frequently Asked Questions – Drug Approval in South Korea

 

What is the MFDS in South Korea?
The Ministry of Food and Drug Safety (MFDS) is South Korea’s key Regulatory authority responsible for regulating pharmaceuticals, medical devices, food, and cosmetics. It ensures product safety, efficacy, and quality under MFDS drug approval South Korea guidelines.
What are the different types of drug approvals in South Korea?
  • New Drug Approval (NDA)/Biological License Application (BLA): This is the most rigorous type of drug approval and is required for all new drugs (including both chemical and biological products) that have not been previously marketed in South Korea.
  • Generic Drug Approval: This type entails a streamlined process for the approval of generic drugs (drugs that are equivalent to previously approved brand-name drugs).
  • Biosimilar Drug Approval: This process is applicable for the approval of biosimilar drugs (drugs that are equivalent to previously approved brand-name biological products).
What are the requirements for submitting a drug application in South Korea?

The Korea drug registration process requires a comprehensive dossier including:

  • Safety and efficacy data
  • CMC documentation (DS & DP)
  • GMP compliance
  • Administrative documentation

These align with MFDS guidelines for drugs and include inspections and bridging data where required.

What is the role of the GCP regulations in the drug approval process in South Korea?
The Good Clinical Practice (GCP) regulations in South Korea are designed to ensure that clinical trials are conducted ethically and in a way that protects the rights of the human subjects. The MFDS often inspects clinical trial sites to ensure that sponsors are compliant with GCP regulations during the NDA/BLA review process.
What are the post-approval requirements for drugs in South Korea?
License holders of NDA and BLA applications in South Korea are required to submit periodic safety reports and periodic risk management plan reports (including Post-marketing Surveillance [PMS] results). The MFDS may also request additional post-marketing clinical study results in case of accelerated approval. These are critical components of the drug approval process in South Korea lifecycle.
What is the role of the KODC in the drug approval process in South Korea?
The Korea Orphan Drug Center (KODC) is a government agency that provides support to developers of orphan drugs, which are drugs that are intended to treat rare diseases. The KODC facilitates the purchase of unapproved orphan drugs from foreign countries.
What is the role of the CPAC in the drug approval process in South Korea?
The Central Pharmaceutical Affairs Council (CPAC) is an advisory body that provides expert advice to the MFDS on the safety and efficacy of drugs. The role and responsibility of the CPAC are similar to that of the United States Food and Drug Administration’s (US FDA’s) Advisory Committee, which comprises scientists, physicians, and other experts.
Does South Korea offer any expedited pathways for drug approvals?

Yes, South Korea offers a few expedited pathways for drug approvals, such as:

  • Priority Review: This pathway is available for drugs that treat serious or life-threatening conditions and offer significant benefits over existing therapies.
  • Conditional Approval: This pathway allows for the early marketing authorization of drugs based on promising but limited clinical data against the condition that further post-marketing studies will be conducted.
  • Breakthrough Therapy Designation: This designation is provided to drugs carrying preliminary clinical evidence of substantial improvement over existing therapies for serious or life-threatening conditions, and designated drugs would go through a priority review.
Can foreign pharmaceutical companies apply for drug approvals in South Korea?
Yes, foreign pharmaceutical companies can apply for drug approvals in South Korea. However, they must have a local representative in South Korea who can handle the application process and ensure compliance with all the relevant regulations.
Does the MFDS offer any incentives for the R&D of new drugs in South Korea?
No, the MFDS offers limited support to pharmaceutical companies. It provides only Regulatory assistance for drug development planning and grants some benefits to innovative companies in Korea.
What are the recent trends in the drug approval process in South Korea?
  • Increased focus on patient-centered drug development.
  • Accelerated drug approvals for unmet medical needs.
  • Increased use of digital technologies for Regulatory purposes.
  • Harmonization with international drug Regulatory standards.