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Regulatory Services for Biologics in South Korea
Ensuring Regulatory Compliance for Biologics, From Strategy to Registration and Post Approval Maintenance
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
- Recombinant DNA products
- Blood and blood-derived products
- Recombinant DNA products
- Vaccines
- Allergenics
Artixio’s Services in South Korea for Biologics
From Development to Product Lifecycle Management
Pre-Registration
- Regulatory Intelligence & Strategy
- Pre-submission meetings
- Dossier Preparation
Registration
- Submission of Application
- Clinical Trials Support
- Response to Queries
- Medical Writing
- Labeling and Artwork
- Import License
Post Market Maintenance
- Post Approval Life-cycle management
- Ongoing Regulatory Intelligence and Monitoring
- Line Extensions
- Advertisement & Promotional Material Review
- Pharmacovigilance
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.
Why Artixio?
Strong Regulatory Insights from our regulatory specialists.
End-to-End Support: From conceptualization to post-market compliance
120+ Countries with Expert Regional Regulatory Teams
Ensure ................. biologics/ biosimilar product licence compliance
Industry Recognized (CPHI Pharma Awards 2024) Tech-Enabled, Regulatory Intelligence driven Services
Responsive, collaborative regulatory services.
ISO 9001:2015, Quality Driven Services Platform
Customer Focused, Nimble Team
KPI based, continual process excellence
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.
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