February 28, 2025

Introduction

South Korea is a significant player in the pharmaceutical and biotechnology industries, offering a robust regulatory framework for drug approvals. The Marketing Authorization Application (MAA) process in South Korea is governed by the Ministry of Food and Drug Safety (MFDS). This blog provides an in-depth guide on the MAA process, key requirements, and regulatory expectations to help pharmaceutical companies navigate the approval process efficiently.

Regulatory Authority: The Role of MFDS

The Ministry of Food and Drug Safety (MFDS) is responsible for evaluating and approving pharmaceutical products in South Korea. It ensures the safety, efficacy, and quality of drugs before they enter the market. The MFDS also aligns its regulations with global standards such as those of the ICH (International Council for Harmonization) and WHO (World Health Organization).

Key Regulations Governing MAA in South Korea

Pharmaceutical companies must comply with the following key regulations while submitting an MAA in South Korea:

  • Pharmaceutical Affairs Act – Governs the manufacturing, importation, and sale of drugs.
  • Regulations on Safety of Pharmaceuticals – Outlines pharmacovigilance and post-marketing surveillance requirements.
  • Good Manufacturing Practice (GMP) Regulations – Ensures quality control in drug production.
  • Guidelines on Drug Approval Review – Provides detailed requirements for clinical and non-clinical data submission.

Types of Marketing Authorization Applications (MAAs)

The MFDS recognizes different types of MAAs based on the drug category and regulatory pathway:

  1. New Drug Application (NDA) – For novel drugs with new active substances.
  2. Generic Drug Application (GDA) – For generic versions of approved drugs.
  3. Biologics License Application (BLA) – For biological products, including biosimilars.
  4. Orphan Drug Application – For drugs treating rare diseases, with incentives such as fast-track approval.
  5. Over the Counter (OTC) Drug Application – For non-prescription drugs.

The Marketing Authorization Process

Step 1: Pre-Submission Consultation (Optional but Recommended)

Companies can engage with MFDS for a pre-submission consultation to clarify requirements, data expectations, and potential regulatory hurdles.

Step 2: Submission of the Application

The MAA dossier must be prepared following the Common Technical Document (CTD) format, which includes:

  1. Module 1 – Administrative and regional information (cover letter, application forms, labeling, etc.)
  2. Module 2 – Summary of quality, preclinical, and clinical data
  3. Module 3 – Quality (pharmaceutical data and GMP compliance)
  4. Module 4 – Non-clinical (toxicology, pharmacology, ADME studies)
  5. Module 5 – Clinical (clinical trial data, efficacy, and safety studies)

Step 3: Review and Evaluation by MFDS

MFDS conducts a detailed review in the following stages:

  • Administrative Review – Ensures completeness of the dossier.
  • Scientific Review – Assesses quality, safety, and efficacy data.
  • GMP Inspection – Evaluates manufacturing facilities for compliance.
  • Advisory Committee Review (if required) – Additional expert opinion for complex cases.

Step 4: Approval or Request for Additional Information

  • If the data is satisfactory, marketing authorization is granted.
  • If additional data is needed, MFDS issues a Request for Information (RFI), requiring a response within a stipulated timeline.

Step 5: Post-Approval Compliance

After approval, companies must adhere to:

  • Pharmacovigilance requirements – Periodic safety update reports (PSURs) and adverse event reporting.
  • Post-marketing surveillance studies – Mandatory for certain drugs.
  • Renewal of Authorization – Typically required every 5 years.

Expedited Regulatory Pathways

South Korea offers accelerated approval pathways for certain drugs:

  1. Priority Review – For drugs addressing unmet medical needs.
  2. Conditional Approval – For rare disease treatments with limited clinical data.
  3. Fast-Track Approval – For drugs with significant therapeutic benefits.

Common Challenges and How to Overcome Them

  1. Regulatory Variability – MFDS requirements may differ from other global agencies. Engaging a local regulatory expert can help bridge gaps.
  2. Language Barrier – Applications must be submitted in Korean. Partnering with local consultants ensures compliance.
  3. Complex Clinical Data Requirements – Aligning clinical trials with MFDS expectations early in the process prevents delays.

Conclusion

Navigating the Marketing Authorization Application (MAA) process in South Korea requires a thorough understanding of MFDS regulations, submission requirements, and post-approval obligations. Pharmaceutical companies must plan strategically, ensuring regulatory compliance and engaging with experts to facilitate a smooth approval process. With the right approach, South Korea offers a dynamic and lucrative market for pharmaceutical innovations.

For further assistance in regulatory affairs, dossier preparation, or compliance with MFDS requirements, feel free to reach out to our team of experts at Maven!