MFDS Pharmaceutical Compliance Support in South Korea

Get expert pharmaceutical compliance consulting in South Korea. Artixio supports MFDS submissions, audits, regulatory strategy, and product lifecycle compliance.

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).

Pharma Compliance Consulting & MFDS Support 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.

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:

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

Full Regulatory Support for Market Entry into South Korea

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.

What are the categories of Post-Approval Change Submissions as per South Korea MFDS?

As per South Korea MFDS, Post-Approval Changes are submitted in the following categories:

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?

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).

What is the applicable fees for approval of pharmaceutical manufacturing as per the MFDS, South Korea?

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

MFDS Pharmaceutical Compliance Support in South Korea

Pharmaceuticals

Regulatory Affairs

Product Registration

IND (Investigational New Drug)

NDA (New Drug Application)

Technical Writing

Regulatory Strategy

Digital Marketing

Market Access

Regulatory Operations

Pharma Compliance Consulting & MFDS Support in South Korea

In the South Korea, Pharmaceuticals are classified into the following two categories:

Drug Products further includes:

MFDS Approval Process for Pharmaceuticals in South Korea

Following steps are involved to successfully register a pharmaceutical product with South Korea (MFDS):

Artixio provides:

Full Regulatory Support for Market Entry into South Korea

FAQs

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

Industries We Serve in the South Korea

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

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