MFDS Pharmaceutical Regulations & Drug Registration In South Korea: A Complete Regulatory Guide

South Korea has emerged as one of Asia’s most structured and innovation-driven pharmaceutical markets. However, entering this market requires a deep understanding of MFDS pharmaceutical regulations, drug registration pathways, and post-marketing compliance obligations.

The Ministry of Food and Drug Safety (MFDS) governs every phase of a medicine’s lifecycle from clinical trials and Investigational New Drug (IND) approvals to manufacturing inspections, labelling compliance, and pharmacovigilance.

This comprehensive guide by Maven Regulatory Solutions explains how pharmaceutical registration works in South Korea, covering drug classification, approval timelines, GMP, labeling rules, clinical trials, import requirements, and lifecycle management using professional yet easy-to-understand language for global manufacturers.

South Korea Pharmaceutical Regulatory Authority (MFDS)

The Ministry of Food and Drug Safety (MFDS) is South Korea’s central regulatory body responsible for ensuring the quality, safety, and efficacy of pharmaceutical products.

MFDS collaborates with the National Institute of Food and Drug Safety Evaluation (NIFDS) to scientifically review drug applications, evaluate clinical data, and assess manufacturing quality.

Core Responsibilities of MFDS

• Review and approve new drugs, generics, biosimilars, and orphan drugs
• Regulate clinical trials and IND approvals
• Enforce Good Manufacturing Practices (GMP)
• Monitor post-market drug safety via KAERS & KIDS
• Oversee labeling, advertising, and distribution compliance

Key MFDS Pharmaceutical Regulations

Pharmaceutical companies must comply with multiple MFDS regulations, including:

• Pharmaceutical Affairs Act
• Regulation on Pharmaceutical Approval, Notifications & Reviews
• Regulations on Drug Classification Criteria
• Good Manufacturing Practice (GMP) Regulations
• Regulations on Safety of Pharmaceuticals
• Regulation on Renewal of Drug Approvals
• Regulation on IND Approval

Drug Classification in South Korea (MFDS)

MFDS classifies pharmaceuticals into drug products and pharmaceutical ingredients (APIs).

Drug Product Categories

Prescription vs OTC Classification

This classification directly affects market authorization, labeling, advertising, and distribution strategies.

MFDS Pharmaceutical Registration Process

South Korea Drug Approval Workflow

Marketing Authorization Validity

• 5 years validity
• Renewal application required 6 months before expiry

MFDS Registration Fee Structure (Indicative)

(Fees subject to MFDS updates)

Documents Required for MFDS Drug Registration

New Drug Applications

• Safety & efficacy data
• Clinical trial reports
• Quality & stability data
• API & DMF documentation
• GMP inspection records
• Patent certificates (if applicable)

Generic Drugs

• Bioequivalence study reports
• Quality & manufacturing data

Good Manufacturing Practice (GMP) Compliance

MFDS GMP guidelines align with ICH and WHO standards.

MFDS GMP Annex Coverage

MFDS Labeling Requirements

Pharmaceutical labeling must include:

• Product name & strength
• Manufacturer / importer details
• Batch number & expiry date
• Storage conditions
• Dosage & administration
• Safety warnings
• Prescription or OTC designation
• Korean Pharmacopoeia compliance

Clinical Trial & IND Requirements (MFDS)

Clinical trials in South Korea require IND approval for:

• New drugs
• New dosage forms
• New routes of administration
• New indications

IND Submission Documents

• IND application form
• Clinical trial protocol
• Investigator’s brochure
• GMP compliance proof
• Informed consent forms
• Non-clinical & clinical data

Import & Distribution Compliance

Post-Marketing Surveillance & Pharmacovigilance

MFDS monitors drug safety via:

• KAERS (Korean Adverse Event Reporting System)
• KIDS (Korea Institute for Drug Safety & Risk Management)
• Periodic Safety Update Reports (PSURs)
• Risk Management Plans (RMPs)
• Product recalls & audits

Why MFDS Compliance Matters

Non-compliance can result in:

• Administrative penalties
• Product suspension or recall
• Market authorization cancellation
• Reputational damage

How Maven Regulatory Solutions Supports You

Maven Regulatory Solutions provides end-to-end MFDS pharmaceutical regulatory consulting, including:

• Drug registration strategy
• IND & clinical trial support
• GMP inspection readiness
• Labeling & lifecycle compliance
• Post-marketing surveillance support

Frequently Asked Questions (FAQs)

Q1. What is the validity of MFDS drug approval?
A. 5 years, renewable 6 months before expiry.

Q2. Is prior FDA or EMA approval helpful?
A. Yes, it supports faster MFDS scientific review.

Q3. Can approvals be withdrawn?
A. Yes, via formal cancellation application to MFDS.

Q4. Who manages pharmacovigilance in Korea?
A. KIDS through KAERS.