July 27, 2025

South Korea has one of the biggest and most advanced pharmaceutical markets in Asia. In 2023, it was worth about KRW 25 trillion (~USD 18.6 billion) and is growing 4–6% per year. With strong hospitals, modern healthcare, and good protection for patents, it is a good market for global pharma, biotech companies, and service providers.

 

Key Market Highlights

  • Second biggest pharma market in Asia-Pacific (after Japan) and among top 15 in the world
  • Main products: prescription drugs, biologics/biosimilars, over the counter (OTC) medicines, advanced therapies, and medical devices
  • Government supports pharma research, innovation, and digital healthcare

 

Regulatory Authority

The Ministry of Food and Drug Safety (MFDS) controls drug rules:

  • Approves drugs and clinical trials
  • Inspects manufacturing sites (K-GMP)
  • Checks drug safety (pharmacovigilance)
  • Approves product labels

MFDS rules follow international standards like ICH, PIC/S, and WHO.

 

Drug Registration Pathways

  • New Drug Applications (NDAs): Submit full CTD with quality, safety, and effectiveness data
  • Generics: Need bioequivalence studies; process is faster than NDAs
  • Imported Drugs: Foreign companies must have a local representative (MAH)
  • Fast Approval: Available for important or innovative drugs

 

Dossier & Clinical Trials

  • Submissions must be in CTD format, some parts in Korean
  • Clinical trials need MFDS IND approval; local data is usually preferred
  • Using local CROs is common, and IRB approval is needed

 

Manufacturing & GMP (K-GMP)

  • All manufacturing sites must be K-GMP certified
  • MFDS inspects the sites
  • Certification is renewed every 3 years
  • Being part of PIC/S can make approvals faster

 

Labeling, Packaging, and Post-Market

  • Labels and product info must be in Korean
  • Products need tamper-proof packaging and MFDS-approved leaflets
  • Must do post-market surveillance and report side effects through KOELSA

 

Market Access & Reimbursement

  • South Korea has a single-payer system managed by HIRA and NHIS
  • Need MFDS approval before asking for reimbursement
  • Pricing is decided based on cost-effectiveness and health assessments (HTA)

 

Recent Trends

  • Biosimilars & Biologics: South Korea is strong in research and manufacturing
  • Digital regulation: eCTD submissions and e-labeling are being used
  • Strong IP Protection: Data exclusivity 6 years, patent extensions allowed

 

Market Entry Strategy

To enter South Korea:

  1. Appoint a local agent (MAH)
  2. Prepare IND/NDA in CTD or eCTD format
  3. Make sure all sites follow K-GMP rules
  4. Apply for reimbursement via HIRA
  5. Set up drug safety monitoring

 

How Maven Can Help

Maven can help with:

  • Planning regulatory strategy
  • Preparing dossiers and CTD submissions
  • Ensuring K-GMP readiness
  • Filing K-DMF (API)
  • Supporting clinical trials and safety reporting
  • Helping with labeling, translation, and reimbursement

 

Conclusion

South Korea is a modern and innovative market with strict rules. Companies need local knowledge and expert support to succeed. Maven can help with regulatory, clinical, and business guidance in South Korea.