Pharma Regulatory Affairs Consulting in South Korea

End-to-end Regulatory Affairs right from Strategy, Registration, Operations to Post Market Lifecycle Maintenance

Services We Offer

Artixio has been successfully working with 50+ global pharmaceutical companies in providing go to market strategies for their products. Our team comes with 30+ years of expertise in navigating the regulatory landscape within Korea by providing right approach and solutioning by catering to major therapeutic area and novel drugs.

Right from development to registration and post approval support, Artixio provides comprehensive, integrated, regulatory and market intelligence driven services across strategy, writing, dossier preparation, publishing, labelling, artwork, ad-promo and regulatory information management.

Pharmaceutical Registration in South Korea (MFDS)

Pharmaceutical registrations and regulations are managed by Ministry of Food and Drug Safety (MFDS) in South Korea. Within the MFDS, the Pharmaceutical Safety Bureau, has the accountability for the review, approval, and regulation of pharmaceutical products in South Korea. The drugs are regulated under the Pharmaceutical Affairs Act, South Korea.

Classification of Pharmaceuticals in South Korea (MFDS)

To begin the Drug registration process in South Korea, it is important to start with classifying the product based on their product ingredients and the status of molecules in South Korea. The MFDS classifies drugs as follow:

New drugs – Any new pharmaceutical material that is different in chemical structure or original composition from pharmaceutical products previously approved in Korea, or a multiple preparation containing a new material as an active drug substance.

Pharmaceuticals that require data submission – Drugs which are not classified a new drug but needs evaluation of safety and efficacy e.g., pharmaceuticals with enhanced effectiveness, new composition of active drug substance, and pharmaceuticals administered via new route of administration.

Generic drugs – Pharmaceutical product which is referenced with a new drug already approved in Korea. The new drug is presented as a reference drug with respect to the active ingredient, dosage form, and strength.

Good Manufacturing Practices (GMP) Regulation for medicinal products

The Good Manufacturing Practices (GMP) for Medicinal Products (No.2021-87, Nov 4, 2021) specifies detailed requirements for enforcement, expiration dates of GMP compliance certificates, and submission of documents for certain medicinal products.

The GMP clearance is a mandatory step which covers various annexes under different acts and regulations, detailing procedures for GMP compliance, validation methods, and contract manufacturing and analysis.

MFDS being a formal member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international body that harmonizes GMP standards across global regulatory agencies decreasing chances of onsite inspection during GMP clearance process in Korea.

Registration Process for Pharmaceuticals in South Korea (MFDS)

MFDS grants a pharmaceutical license in Korea for five years. The license holder must file a renewal application with the MFDS six months before expiration.

The fee for obtaining a marketing license for medicinal products is approx. USD 3500 and the timeline can vary from 12-18 months’ time.

MFDS considers prior approval from the USFDA or the EMA

MFDS accepts the approvals from EU and USA as part of reference countries. The approved products in these countries are taken into consideration during the process of evaluation leading to expedited registration process.

Post Marketing Surveillance

The MFDS has a well-equipped pharmacovigilance system to receive, process, and evaluate adverse event reporting. The system identifies patterns, trends, and potential safety signals associated with specific drugs or drug classes. MFDS may require companies to submit Risk management Plans based upon product category to assess overall risk and its management.

Artixio offers a range of services to assist pharmaceutical companies with product registration in South Korea:

Regulatory Intelligence & Strategy
Medical & Technical Writing
Due Diligence and Gap Analysis
Dossier Preparation and compilation
Dossier Publishing & Submission
Product Registration
Marketing Authorization Holder (MAH/LR)
Investigation New Drug Application (IND) / Clinical Trial Application (CTA)
New Drug Application (NDA) / Marketing Authorization Applications (MAA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review
Distributor and Import Assistance

Collaborate with Artixio’s South Korean Expertise with Seamless Global Delivery

Successful Approvals and Product Lifecycle Maintenance for 300+ products
Diverse Products Experience across Complex Products Categories and Therapeutic Areas
Strong Regional Expert with 30+ years of experience
Proven Experience in End-to-End Product Value Chain from Concept to Commercialization
Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
Intelligence driven, global regulatory services supported by Dvarka
ISO 9001:2015 quality standards governed services
Customer focused, flexible services and solutions
Flexible Business Model including project based, managed services and FTE staffing model
Hybrid-Local-Centralized Support across Regulatory functions

FAQS About Regulatory Affairs

1. What is the name of regulatory body for pharmaceutical registrations in South Korea?

The Ministry of Food and Drug Safety (MFDS) is the authority responsible for the approval, regulation, and post-marketing surveillance of pharmaceuticals in South Korea.

2. Do foreign pharmaceutical companies need a local representative in Korea?

Yes. Pharmaceutical Companies without a local entity in Korea must appoint a Korean Marketing Authorization Holder (MAH) or local agent who would be legally responsible for the product in Korea and will handle all communications with MFDS.

3. Is local clinical trial data required?

Mostly MFDS accepts foreign clinical trials if it includes study of East Asian populations. However, MFDS may require bridging studies/ local testing based upon drug category, indication.

4. Can pharmaceutical companies advertise their product in Korea upon approved?

Yes, advertising of pharmaceutical is permitted once the promotional materials are thoroughly reviewed and approved as per MFDS guidelines. Claims must scientifically align to the approved labels.

5. Are there expedited approval pathways in South Korea?

Yes, MFDS do have accelerated pathways based on the following attributes:

Priority Review: for serious and public health needs
Fast Track Designation: Products reviewed based on their usage and drug designation
Conditional Approval: Specially for rare or life-threatening diseases with limited alternatives

6. Is Korean language mandatory for submissions?

Yes, documents submitted to MFDS must be translated in Korean, this is done for accessibility of end user and must state the usage, warnings and indication. The translation of documents should be performed by a certified translator.

7. Can regulatory affairs consulting companies help with registration in Korea?

Absolutely. Artixio has successfully supported 50+ pharmaceutical companies with registering their products with MFDS with 100% success rates. Our team come with 30+ years of expertise in managing south Korean pharmaceutical registrations and post marketing support. Right from the strategy to commercialisation of pharmaceutical products.