South Korea Generic Medicine Registration- A Strategic Guide

South Korea Market Overview 

South Korea’s pharmaceutical market is among the fastest growing in Asia, driven by its advanced healthcare infrastructure, aging population, and strong emphasis on innovation. The market is characterized by an increasing demand for affordable generic medicines, making it a lucrative destination for global pharmaceutical companies.

While the government encourages the use of generics to manage healthcare costs, stringent Regulatory requirements ensure the safety, efficacy, and quality of these products. Therefore, successful entry into this market demands a strategically crafted approach and meticulous execution, particularly in terms of compliance with Good Manufacturing Practice (GMP) and dossier expectations.

Registration Process in South Korea

The registration of generic medicines in South Korea is overseen by the Ministry of Food and Drug Safety (MFDS). Key steps in the process include:

1. Dossier Preparation and Submission:
   
   1. Prepare the Common Technical Document (CTD), which includes Modules 1 to 5: administrative documents, quality data (CMC), non-clinical and clinical data. For generics, clinical data is usually limited to bioequivalence studies unless otherwise required by MFDS.
2. Bioequivalence Studies:
   
   1. Demonstrate that the generic product is bioequivalent to the reference product through clinical trials or existing data.
3. MFDS Review:
   
   1. The submitted dossier undergoes a comprehensive review for quality, safety, and efficacy, with possible queries raised for clarification.
4. Approval and Pharmacovigilance (PV) activities:
   
   1. Upon approval, the product is registered, and applicants must adhere to pharmacovigilance (PV) activities including the designation of a Qualified Person for Pharmacovigilance (QPPV) responsible for safety management, adverse event (AE) monitoring, collection, analysis, reporting, and the establishment of standard operating procedures.

Basic Regulatory Requirements  

1. Good Manufacturing Practice (GMP):
   
   1. All manufacturing sites must comply with MFDS GMP standards foreign manufacturers may be exempt from on-site inspections if certified under PIC/S GMP or if mutual recognition agreements are in place, but MFDS approval is still required.
2. Bioequivalence Data:
   
   1. For generics, bioequivalence studies must establish pharmacokinetic similarity to the reference product. MFDS generally requires local BE studies unless justified with internationally accepted data.
3. Labeling Requirements:
   
   1. Product labeling and inserts must be in Korean and approved by MFDS. They must include the product’s name, ingredients, usage, dosage, and safety information.
4. Local Representation/Marketing authorization holder (MAH)
   
   1. Foreign companies must appoint a locally registered legal representative or marketing authorization holder (MAH) to act as the applicant for product registration.
5. Regulatory Fee Submission:
   
   1. Fees must be paid as part of the registration process, varying by product type and complexity.

Freyr’s Successful Case: Regulatory Publishing for a USA-Based Company 

Client Overview:

 A USA-based pharmaceutical company specializing in generic oral and parenteral products sought Freyr’s expertise for the preparation and submission of ANDAs (Abbreviated New Drug Applications) and DMFs (Drug Master Files) in South Korea. The client’s primary goal was to achieve timely approvals with zero deficiencies.

Project Details:

1. Strategic Planning and Roadmap Development:
   
   1. Devised a submission strategy tailored to MFDS requirements for oral and parenteral formulations, ensuring complete compliance.
2. Regulatory Document Compilation:
   
   1. Prepared CTD-compliant ANDA and DMF dossiers, covering quality, safety, and clinical sections.
   2. Conducted a thorough gap analysis to resolve discrepancies in technical data before submission.
3. Bioequivalence Study Support:
   
   1. Assisted in the design and documentation of bioequivalence studies to meet MFDS standards.
4. End-to-End Publishing Services:
   
   1. Managed the entire submission lifecycle, including dossier preparation, validation, and communication with MFDS.
   2. Addressed MFDS queries promptly, maintaining submission timelines.

Outcome:

• Zero Deficiencies: The client received approval for both ANDA and DMF submissions with no queries or deficiencies raised by MFDS.
• Timely Approvals: Enabled the client to enter the South Korean market within their targeted timeline.
• Streamlined Processes: Freyr’s publishing expertise reduced the regulatory burden, allowing the client to focus on other strategic initiatives.

Ready to Enter South Korea’s Growing Pharmaceutical Market? 

With its rigorous Regulatory requirements and evolving market dynamics, entering South Korea’s pharmaceutical space requires precision, foresight, and a reliable local partner.

Freyr Solutions offers comprehensive regulatory support including:

• CTD dossier compilation aligned with MFDS guidelines
• Guidance on Common Technical Document format and compliance
• Execution and documentation of bioequivalence studies
• Appointment support for marketing authorization holders
• Regulatory publishing of ANDAs and DMFs
• Post-approval PV and GMP compliance strategies

Freyr’s experience across South Korea’s Regulatory framework ensures your company is well-positioned to navigate challenges and achieve rapid, compliant market access.

FAQs

Q1) How long does it take to register a generic medicine in South Korea?

The registration timeline typically ranges from 8 to 12 months. This duration may vary depending on dossier completeness, MFDS responsiveness, the need for additional data, and the complexity of the product, etc.

Q2) Can foreign pharmaceutical companies apply for registration directly with MFDS?

No, foreign companies must appoint a locally registered entity or representative to act as the applicant for product registration. This ensures that the regulatory authority has a point of contact within South Korea.

Q3) Are bioequivalence studies mandatory for generic medicines in South Korea?

Yes, bioequivalence studies are mandatory to prove that the generic medicine is pharmacokinetically like the reference product. These studies are typically required for oral dosage forms, like tablets or capsules, but may not be necessary for other formulations (e.g., topical, ophthalmic, inhalation, injectable, etc) if they do not have the same pharmacokinetic characteristics as the original drug. It is a critical part of the registration process and must adhere to MFDS guidelines.