Artixio

Regulatory Services for Pharmaceuticals in South Korea

End-to-End Strategic Regulatory Partner for Pharmaceuticals in South Korea

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

The Ministry of Food and Drug Safety (MFDS) is the National Regulatory Authority regulating the registration of pharmaceuticals with South Korea.
In the South Korea, Pharmaceuticals are classified into the following two categories:
Drug Products further includes:
Before registering the product with South Korea, it is crucial to identify the proper classification category of a product. At Artixio, we help our clients to determine the appropriate Product Category and regulatory requirements in compliance with the South Korea MFDS.

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

Artixio provides:

FAQs

What is the validity period of drug product approval with MFDS?
The validity period of a drug product is five years from the date of product approval.
As per South Korea MFDS, Post-Approval Changes are submitted in the following categories:
  • Annual report
  • Immediate report
  • Prior Change Approval 

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 

Yes, the Global Innovative products on Fast Track (GIFT) Program under the MFDS promote expedited regulatory review of global innovative products to facilitate the market launch of innovative medicinal products for treatment of life-threatening or serious diseases, such as cancers, or rare diseases. Through the GIFT, the assessment timeline is shortened to up to 75% of usual review time (120 to 90 working days).
As per the MFDS, South Korea the applicable fees for approval of pharmaceutical manufacturing through online is 385,700 KRW and through in person/mailing is 426,300 KRW.
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

India
Vietnam
Mexico​
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines

Industries we serve

Pharmaceuticals

Cosmetics

Nutrition

Medtech

Biologics

Veterinary

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