Medicinal Products

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.