Biologics Regulatory Affairs Support In South Korea

Biologics Product Registration and Regulatory Services in South Korea

Ensuring Regulatory Compliance for Biologics, From Strategy to Registration and Post Approval Maintenance. Our team supports full regulatory planning for biologics product registration in South Korea, ensuring compliance with MFDS standards and smooth market access.

Biologics

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Artixio’s Services in South Korea for Biologics

South Korea is a global hub for biologics and biosimilars. The Korean pharmaceutical market is estimated to be $1.16 billion by 2027 & CAGR of 21.6%. Artixio offers end-to-end regulatory services to global manufacturers, facilitating smooth approval with strong understanding of international regulatory frameworks and provide strategic, efficient, and market-ready pathways for biologics entering the South Korean market.

Classification of Biologics in South Korea

South Korea Regulatory Support for Biologics Product Approval

From Development to Product Lifecycle Management

Pre-Registration

Registration

Post-Market Maintenance

Process for Registration of Biologics in South Korea

The Ministry of Food and Drug Safety (MFDS) is the Regulatory body regulates the Biologics in South Korea. Biologics License Applications (BLAs) must adhere to the format outlined by the Ministry of Food and Drug Safety (MFDS), often following the Electronic Common Technical Document (eCTD) structure.

Full Regulatory Support for Market Entry into South Korea

Why Choose Artixio for Biologics Compliance and Product Registration with MFDS?

FAQs

What is South Korea’s New Regulatory Data Protection System?

The new regulatory data protection system in South Korea grants data exclusivity to Marketing Authorization applications filed from 21st Feb 2025. Application filed before 21st Feb 2025 follow under old Re-examination system.

Data Protection Period for Biologics?

Data protection period is same for both Biologics and Drug. New Biological Entity- 6 years from date of Marketing approval (MA) Orphan Product – 10 years from date of MA Paediatric Use – Add on 1 year to existing exclusivity.

How long does it take to get biologics approved in South Korea?

For Standard application pathway, after submission of Biologics License Application (BLA) MFDS will take 115-180 days for review and decision by MFDS.

Which electronic portal used to submit regulatory applications for biologics in South Korea?

Applicant must submit application to Health authority as electronic documents through KiFDA online system.

How can foreign manufacturer register their product in South Korea?

Foreign manufacturers require South Korean business entity with valid manufacturing license to register product. Applications for consultation or submission can be prepared and submitted to MFDS through the Local representatives. At Artixio, we also provide Local Representative services to expedite product registration and regulatory compliance in South Korea.

Biologics Regulatory Support In South Korea