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Korean Drug Regulation Summary

The Ministry of Food and Drug Safety (MFDS) in Korea oversees the approval and regulation of drugs and biologics, similar to the FDA in the USA. The new drug approval process includes Clinical Trial Authorization, clinical trials, and a New Drug Application, with a standard review timeline of approximately 12 months. Post-marketing surveillance is mandatory for new drugs, and pricing negotiations are required for reimbursement after approval.

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16 views2 pages

Korean Drug Regulation Summary

The Ministry of Food and Drug Safety (MFDS) in Korea oversees the approval and regulation of drugs and biologics, similar to the FDA in the USA. The new drug approval process includes Clinical Trial Authorization, clinical trials, and a New Drug Application, with a standard review timeline of approximately 12 months. Post-marketing surveillance is mandatory for new drugs, and pricing negotiations are required for reimbursement after approval.

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hsjeon
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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1.

Regulatory Authority
Ministry of Food and Drug Safety (MFDS) (식품의약품안전처)

Governs the approval, manufacture, import, distribution, and post-market surveillance of drugs and
biologics in Korea.

Similar role to the FDA (USA) or EMA (EU).

2. Drug Classification
Chemical Drugs

Biologics (e.g., vaccines, botulinum toxins, blood products)

Advanced Therapies (e.g., cell & gene therapy)

Medical Devices and Quasi-drugs handled separately

3. New Drug Approval Process


A. Clinical Trial Authorization (CTA)
Apply to MFDS before starting human trials.

Requires preclinical data (GLP), protocol, and GMP-compliant investigational product.

B. Clinical Trials (Phases I–III)


Must be conducted in compliance with Korean GCP.

Local trials often required, especially for first-in-class products.

C. New Drug Application (NDA)


Submit full Common Technical Document (CTD format)

Modules 1–5

Review includes safety, efficacy, quality, labeling, and risk management plans.

D. Review Timeline
Standard review: ~12 months

Priority review: ~6 months (for orphan drugs, public health emergencies)

4. GMP and Facility Inspection


K-GMP (Korean Good Manufacturing Practice) required for domestic and imported drugs.

On-site inspection by MFDS before approval.

5. Post-Marketing Surveillance (PMS)


Mandatory 4–6 years of PMS for new drugs.

Adverse event reporting is required.

Re-examination and license renewal may be required.

6. Import & Foreign Manufacturer Registration


All imported drugs must be registered with MFDS.

Overseas manufacturing sites must be pre-approved and inspected by MFDS.

7. Pricing and Reimbursement


After approval, price negotiation with Health Insurance Review and Assessment Service (HIRA) and
National Health Insurance Service (NHIS) is needed for reimbursement.

Drugs not reimbursed can still be marketed but at private cost.

8. Orphan Drugs and Accelerated Pathways


MFDS offers orphan designation, priority review, and conditional approval for critical unmet needs.

Expedited approval is possible for life-threatening or rare diseases.

9. Recent Trends
Increased alignment with ICH guidelines (Q, S, E, M series)

Growing emphasis on biosimilars, digital health, and real-world evidence

Implementation of UDI (Unique Device Identification) and electronic submission (e-CTD)

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