South Korea Drug Registration and Approval process - Overview
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 is 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 markets.
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 in South Korea.
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 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 South Korea.
By leveraging drug classification systems, Freyr can help you take your product global while ensuring compliance with Regulatory requirements.
Drug Registration & Approval
Based on the MFDS regulations, the registration of drug in South Korea depends on the Regulatory classification of the drug product. 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 requests 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 application for review.
- The MFDS conducts a review about NDA application dossiers in each review departments by the sections of data like “Safety & Efficacy”, “CMC (test method & specification), and GMP.
- Each review departments can request supplement data if the dossier does not meet MFDS clinical trial or approval requirements after 1st review.
- GMP review department can make a MFDS inspection for the manufacturing sites of drug product and drug substance in foreign countries. The schedule of site inspection will be arranged between MFDS and manufacturing site. GMP review department can request supplement data after site inspection.
- If no further documentation or supplementary data is required, the MFDS issues the applicant 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 it should be renewed on the basis of a re-evaluation of the benefit/risk balance by the competent Regulatory authority.
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 and Approval requirements.
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.