The drug registration process in Korea is a meticulously structured system overseen by the Ministry of Food and Drug Safety (MFDS). This process is designed to ensure that all pharmaceuticals meet stringent standards of safety, efficacy, and quality before they are made available to the public. The journey from drug development to market approval involves several critical stages, including classification, data submission, comprehensive review, and post-approval obligations.
Classification of Pharmaceuticals
Understanding the classification of pharmaceuticals is fundamental to navigating the registration process in Korea. The MFDS categorizes pharmaceuticals into two primary groups:
- Drug Products: These are finished products intended for consumer use.
- Pharmaceutical Ingredients: These refer to the active substances utilized in the manufacturing of drug products.
Within the category of drug products, further distinctions are made:
- New Drugs: These are pharmaceuticals that contain active substances with a chemical structure or composition not previously approved in Korea. This category also includes combinations that incorporate a new material as an active ingredient.
- Pharmaceuticals Requiring Data Submission: These are not classified as new drugs but necessitate evaluation for safety and efficacy. Examples encompass drugs with new therapeutic effects, novel combinations, modified dosages, or new routes of administration.
- Generic Drugs: These are pharmaceuticals equivalent to existing approved drugs in terms of active ingredients, dosage form, and strength. Typically, they are required to submit bioequivalence data and quality information instead of comprehensive safety and efficacy data.
Approval Workflow
The approval process for pharmaceuticals in Korea involves several meticulously defined stages:
- Submission: Applicants begin by submitting the required documentation to the MFDS.
- Pre-Review: The Drug Review Management Division conducts a preliminary assessment to ensure all necessary information is provided. During this phase, a Product Manager (PM) is assigned to oversee the application.
- Review: Specialized divisions within the MFDS evaluate the submission based on the drug’s therapeutic category. For example:
- Cardiovascular & Neurology Products Division: This division reviews drugs related to cardiovascular and neurological conditions.
- Oncology & Antimicrobial Products Division: This division focuses on evaluating cancer treatments and antimicrobial agents.
- Gastroenterology & Metabolism Products Division: This division assesses drugs intended for digestive and metabolic disorders.
- Bioequivalence Evaluation Division: This division is responsible for evaluating bioequivalence studies, particularly for generic drugs.
- Approval: Upon satisfactory review, the Drug Review Management Division grants approval for the drug.
- Issuance: The Customer Support Office issues the official approval certificate, authorizing the drug for market distribution.
Throughout this process, the Central Pharmaceutical Affairs Advisory Committee (CPAC) may be consulted to provide expert advice, ensuring a thorough and balanced evaluation.
Data Requirements for Approval
The registration dossier for drug approval in Korea includes extensive documentation to ensure compliance with regulatory standards. According to Regulation on Safety of Pharmaceuticals (Ordinance of the Prime Ministerial) Article 9, different sets of data must be submitted depending on the type of drug being reviewed.
For new drugs, the Drug Evaluation Department conducts a thorough review, requiring:
- Safety and efficacy data
- Specifications and test methods
- Drug Master Files (DMF)
- Certificate of manufacturing and marketing for imported pharmaceuticals
- Details of active pharmaceutical ingredient manufacturers
Additional reviews are conducted by other MFDS departments, particularly regarding Good Manufacturing Practice (GMP) compliance, ensuring that all manufacturing sites meet the required production and quality standards.
The dossier must also include comprehensive data on drug products, such as:
- Composition and formulation details
- Manufacturing methods
- Specifications and test methods
- Supportive data on test results
- Reference standards, reagents, and test solutions
- Details of packaging and container materials
Korean Good Manufacturing Practice (K-GMP) Compliance
Ensuring compliance with Good Manufacturing Practice (GMP) standards is a critical component of the drug registration process:
- Inspections: Both domestic and international manufacturing facilities undergo rigorous inspections to verify adherence to GMP standards.
- Documentation: Manufacturers are required to provide detailed records of their quality management systems, manufacturing processes, and quality control measures.
- Certification: Facilities that meet GMP requirements receive certification, which is a prerequisite for product approval and market distribution.
Post-Approval Obligations
After a drug has been approved, manufacturers must fulfill ongoing responsibilities to ensure continued compliance and public safety:
- Pharmacovigilance: This involves the continuous monitoring of the drug’s safety profile and the prompt reporting of any adverse events to the MFDS.
- Quality Assurance: Manufacturers must maintain consistent manufacturing quality and adhere to any updates in regulatory standards.
- Re-Evaluation: Certain drugs may be subject to periodic re-evaluation to ensure they continue to meet safety and efficacy standards over time.
Recent Regulatory Changes in Korea’s Drug Registration Process
Efforts to Expedite Drug Reimbursement
Korea has faced persistent delays in drug reimbursement, with the process taking around four years — far longer than in other advanced markets such as the United States, Japan, and Germany. These delays have resulted in a backlog of innovative drugs that receive approval overseas but remain unavailable to Korean patients due to prolonged reimbursement negotiations. In response to this issue, the Korean government introduced the Approval-Evaluation-Negotiation Linkage System, a pilot program designed to shorten reimbursement timelines for innovative drugs. Under this system, the Health Insurance Review and Assessment (HIRA) and the National Health Insurance Service (NHIS) will evaluate reimbursement applications simultaneously, significantly reducing wait times. The program initially includes two drugs, Qarziba and Bylvay, and is open to other medications that receive fast-track designation.
Enhancements to Drug Review Timelines
In addition to addressing reimbursement delays, the Ministry of Food and Drug Safety (MFDS) has undertaken reforms to expedite drug review timelines. One of the most controversial changes is a substantial increase in drug review fees. Previously, pharmaceutical companies paid approximately $6,000 USD for drug approval reviews, but this fee has now surged to over $300,000 USD. The government justifies this 50-fold increase by emphasizing the need for better resources, including the hiring of highly qualified reviewers to accelerate evaluations. However, the new policy has met resistance from the pharmaceutical industry.
The Korea Research-based Pharma Industry Association (KRPIA) has voiced concerns that the fee increase imposes a significant financial burden on companies, especially those developing treatments for rare diseases or submitting applications for drugs with similar formulations. Industry representatives have proposed several modifications, including a six-month grace period before the new fees take effect, fee reductions for drugs with identical compositions, and exemptions for rare disease drugs.
New Drug Approval System
To further streamline the approval process, Korea implemented a new drug approval system on January 1, 2025. This system introduces several key improvements designed to enhance communication and efficiency. First, the MFDS has assigned dedicated review teams to oversee each drug application, ensuring consistent evaluation and faster processing. Second, drug companies can now consult with MFDS officials up to ten times, a significant increase from the previous limit of three consultations.
Another critical reform is the formal documentation of all interactions between the MFDS and pharmaceutical companies. Previously, much of the regulatory communication was informal, leading to inconsistencies and misunderstandings.
Revisions to GMP Regulations
Recognizing the need for further efficiency, the MFDS has also revised Korean Good Manufacturing Practice (GMP) regulations to simplify the certification process. One of the most significant changes is the reduction in required documentation, cutting the number of required document types from 11 to 4. This simplification reduces the administrative burden on pharmaceutical companies while maintaining high regulatory standards.
Furthermore, the MFDS has relaxed requirements for on-site GMP audits, which were previously mandated every three years for all manufacturing facilities. Under the new system, companies with compliant production sites can now extend their GMP certification by two additional years through written correspondence instead of undergoing a full on-site audit. This change acknowledges that frequent audits may not always be necessary for well-established facilities and helps companies allocate resources more efficiently.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.