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Regulatory Services 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).
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IND (Investigational New Drug)
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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
Trusted Regulatory Partner
Experience in licensing and maintaining 5000+ Products
Client focused support in applicable languages
Global reach with presence in over 120+ countries
Regulatory Expertise Across
Multiple Countries
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