The pharmaceutical product approval process in South Korea is comprehensive, structured, and regulated by the Ministry of Food and Drug Safety (MFDS). It ensures that only safe, effective, and high-quality medicines are made available to the public. Below is a step-by-step outline of the approval process:

1. Application Submission 

Pharmaceutical companies begin by submitting an application to the Ministry of Food and Drug Safety (MFDS), which includes critical data on:

• Standards and test methods
• Safety and efficacy
• Quality control information

2. Preliminary Review 

The Ministry of Food and Drug Safety (MFDS) conducts an initial review to confirm that all required documents and data have been submitted properly. Incomplete applications may be returned for correction.

3. Review by Expert Committees 

For specialized or complex applications, the Central Pharmaceutical Affairs Council or other expert panels provide technical advice and assessment. The involvement of these committees is generally optional and at the discretion of the MFDS.

4. GMP Evaluation 

The MFDS carries out Good Manufacturing Practice (GMP) evaluations and conducts on-site inspections of manufacturing facilities. This step ensures that manufacturing processes and quality controls align with regulatory standards.

5. Review of Quality, Standards, and Test Methods 

As part of the review process, the MFDS conducts a detailed quality assessment, evaluating manufacturing processes, raw materials, product specifications, and stability data to ensure consistent product quality.

The MFDS also reviews the standards and test methods submitted by the applicant, including validation data and analytical procedures, to confirm they are scientifically sound and reliable for ensuring the product’s identity, strength, purity, and safety.

6. Review of Safety and Efficacy 

Detailed evaluation of clinical trial data and other relevant materials is performed to determine the product's safety and effectiveness.

7. Approval or Request for Additional Information 

If the product meets all standards, it is granted marketing authorization. If additional clarification or data is needed, MFDS will issue a formal request to the applicant.

8. Issuance of Approval 

Once all requirements are met and the product is deemed safe and effective, the MFDS issues formal approval for the pharmaceutical product.

 Conclusion 

The MFDS ensures a high level of scientific rigor and transparency throughout the pharmaceutical product approval process. This systematic approach protects public health and supports innovation in the pharmaceutical industry.

How Freyr Can Help 

Freyr provides end-to-end Regulatory support for pharmaceutical product registration in South Korea, including:

• MFDS consultation support
• Dossier preparation and submission
• GMP readiness
• Lifecycle management and post-approval compliance

Looking to navigate South Korea’s regulatory landscape smoothly? Connect with Freyr today.