All You Need to Know About the South Korea Pharmaceutical Market

 The South Korea pharmaceutical market is one of Asia’s most dynamic and rapidly evolving pharmaceutical landscapes. Backed by strong healthcare infrastructure, government investment in R&D, and robust regulatory oversight, offering significant opportunities for global pharmaceutical manufacturers. However, entering this market requires navigating a highly structured and detailed regulatory framework governed by the Ministry of Food and Drug Safety (MFDS).

This blog serves as a comprehensive guide for pharmaceutical manufacturers aiming to establish a compliant and competitive presence in South Korea.

1. Regulatory Authority Overview  in the South Korea Pharmaceutical Market

At the core of South Korea’s pharmaceutical market oversight is the MFDS (Ministry of Food and Drug Safety). Formerly known as the Korea Food and Drug Administration (KFDA), MFDS is responsible for regulating drugs, medical devices, cosmetics, and food. It ensures that pharmaceutical products available in the Korean market comply with the highest standards of safety, efficacy, and quality.

MFDS collaborates with other bodies such as:

• KPBMA – Korea Pharmaceutical and Bio-Pharma Manufacturers Association
• Korea Pharmaceutical Test & Research Institute (KPTR) – For quality testing and certification

 This structured collaboration ensures the pharmaceutical industry in South Korea remains robust, credible, and globally aligned.

2. Drug Registration Pathways 

Pharmaceutical products must undergo one of the following pathways for approval:

a. New Drug Applications (NDAs): 

For innovator drugs containing new active substances, a comprehensive dossier submission is required. This includes detailed data on safety, efficacy, quality, and clinical trials.

b. Generic Drug Registration: 

Generic drugs must demonstrate bioequivalence to the reference product. Applicants are required to submit bioequivalence study data along with quality information, instead of full clinical trial data.

c. Imported Drugs: 

Foreign pharmaceutical companies seeking to market their products in South Korea are required to designate a local representative—commonly referred to as an In-Country Caretaker (ICC). This representative is tasked with overseeing the product registration process with the Ministry of Food and Drug Safety (MFDS) and ensuring full compliance with South Korean regulatory requirements.

d. Expedited Approvals: 

The MFDS offers expedited review pathways for certain categories of drugs, including orphan drugs, treatments for life-threatening conditions, and during public health emergencies. Programs like the Global Innovative product on Fast Track (GIFT) aim to accelerate the review process for qualifying products.

3. Dossier Submission Requirements 

The MFDS accepts dossiers in the Common Technical Document (CTD) format. Key submission components include:

• Module 1: Regional administrative information
• Module 2: Summaries
• Module 3: Quality (CMC)
• Module 4: Non-clinical reports
• Module 5: Clinical studies

Note: Some sections of dossiers must be submitted in Korean, with certified translations of foreign data.

4. Clinical Trials in South Korea 

Clinical trials in Korea require prior IND (Investigational New Drug) approval from MFDS. Local data is often preferred, and sponsors may be required to conduct local clinical trials for certain drugs.

Key considerations:

• Ethical approval is mandatory from IRBs (Institutional Review Boards)
• Bioequivalence studies are a must for generics
• CROs play a vital role in trial execution and monitoring

This reflects the strategic importance of localized data in the Korea pharmaceutical market.

5. GMP Compliance and Inspections  

All manufacturing facilities supplying drugs to Korea must comply with Korean Good Manufacturing Practices (KGMP).

• MFDS conducts on-site inspections both domestically and internationally
• GMP certification is granted per product and facility
• Renewal is typically required every three years
• Facilities must demonstrate strong QC, QA, and documentation controls

6. Labeling and Packaging Requirements 

Labeling and packaging of pharmaceutical products must comply with MFDS guidelines:

• All labels must be in Korean, including usage instructions and precautions
• Serial numbers and barcoding are mandatory for traceability
• Tamper-evident packaging is often required
• For combination products, clear labeling of each component is essential

7. Post-Marketing Surveillance and Pharmacovigilance 

Approved products must undergo ongoing post-marketing surveillance (PMS), which includes:

• Reporting of adverse events within specific timelines
• Submission of Periodic Safety Update Reports (PSURs)
• Risk management plans(RMPs) for high-risk medications
• Batch recalls in case of quality deviations

8. Market Access and Reimbursement  

In Korea, pricing and reimbursement are regulated under the Health Insurance Review & Assessment Service (HIRA):

• After MFDS approval, companies must negotiate with HIR for reimbursement
• Drugs must be demonstrate cost-effectiveness and added value over existing therapies
• Health Technology Assessments (HTA) may be required

Having a local partner with market access expertise is crucial for successful commercialization in the South Korea pharma market.

9. How Freyr Supports Your South Korea Strategy 

Freyr offers end-to-end regulatory support tailored to the South Korean market:

• Regulatory Intelligence Support.
• Regulatory Due Diligence Support.
• South Korea Drug Registration and Approval Process.
• Active Pharmaceutical Ingredient DMF Filing Services.
• Submission Management to Health Authorities (e.g. MFDS).
• Providing Translation Services.
• Data Reliability Inspection.

10. Conclusion 

Successfully entering the South Korea pharmaceutical market requires deep regulatory understanding, cultural nuance, and precise execution. From dossier submission to GMP certification and post-market surveillance, every step demands compliance with MFDS standards.

With Freyr as your trusted partner, you gain local expertise, global experience, and strategic support—ensuring that your product reaches Korean patients efficiently and compliantly.