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Pharmaceutical Consulting in South Korea
End-to-End Strategic Regulatory Partner for Pharmaceuticals in South Korea
Pharmaceuticals
Artixio is a global regulatory service provider company, helping our clients to successfully launch their product in the market and maintaining post-approval surveillance. In the South Korea, we offer a complete support for industries throughout their journey of pharmaceutical commercialization with the Ministry of Food and Drug Safety (MFDS).
Regulatory Affairs
Product Registration
IND (Investigational New Drug)
NDA (New Drug Application)
Technical Writing
Regulatory Strategy
Digital Marketing
Market Access
Regulatory Operations
Pharmaceuticals Regulatory Consultant in South Korea
In the South Korea, Pharmaceuticals are classified into the following two categories:
- Drug Products
- Pharmaceutical Ingredients
Drug Products further includes:
- New Drug
- Generic drug
- State FDAs (every state in India)
Approval Process for Pharmaceuticals in South Korea
Following steps are involved to successfully register a pharmaceutical product with South Korea (MFDS):
Before issuing the Approval, MFDS carries out the inspection of manufacturing sites and management practices
- Overseas manufacturing sites by Pharmaceutical Quality Division
- Domestic manufacturing sites by Medical Product Safety Division at Regional FDAs
Artixio provides:
- Step by step guidance for approval process in South Korea (MFDS)
- GMP Compliance support
- Documents requirements according to product category
- Strategies for easy market entry of the product
- Post Approval Maintenance including renewal of the product license
FAQs
What is the validity period of drug product approval with MFDS?
What are the categories of Post-Approval Change Submissions as per South Korea MFDS?
- Annual report
- Immediate report
- Prior Change Approval
What is the validity of Certificate of GMP Compliance in South Korea?
The validity of Certificate of GMP Compliance is as follows:
Condition | Validity of GMP Compliance Certificate |
First issuance | 3 years from the issue date |
Renewal after inspection | 3 years from the completion date of GMP inspection |
Changes made before expiry (e.g., addition of new dosage forms) | Existing certificate Expiration date stays the same |
Does MFDS offer an expedited regulatory review pathway for pharmaceutical product approval?
What is the applicable fees for approval of pharmaceutical manufacturing as per the MFDS, South Korea?
KRW: South Korean Won
Why Choose Artixio?
Strategies for pre-submission preparation
Support across INDs, NDAs, variations, and renewals
Experience in licensing and maintaining 5000+ Products
Client focused support in applicable languages
Help with Korean-language requirements and labeling
Regulatory Expertise Across
Multiple Countries
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