South Korea Drug Registration and Approvals

South Korea Drug Registration and Approvals - Overview

South Korea is one of the emerging global markets for pharmaceutical products. Manufacturers must obtain approval from the Ministry of Food and Drug Safety (MFDS), which is responsible for South Korea drug registration and approval along with the drug registration process in South Korea.  To expedite the import of important innovative biologic agents used for public health emergencies, in April 2021, South Korea’s Ministry of Food and Drug Safety (MFDS) announced that a new Regulatory framework for the South Korea drug registration and approval process would allow foreign drug manufacturers to export their drugs to Korea without having to provide country-of-origin certificates.

Freyr’s experts will evaluate the submission data accuracy against South Korea’s Ministry of Food and Drug Safety (MFDS) regulations to ensure compliance at all stages and thus enable accurate submission for quick Health Authority (HA) reviews, pharmaceutical product registration, and medicinal products drug registration process in South Korea.

Freyr supports Pharmaceutical product registration in South Korea, which includes assistance in registration via different pathways based on the product type. Freyr also provides post-approval support for license renewals, dossier updates, and product maintenance & compliance according to South Korea’s Ministry of Food and Drug Safety (MFDS) guidelines. With end-to-end expertise in Regulatory Affairs, Freyr is the ideal compliance partner for pharmaceutical products’ registration in South Korea.

Drug Classification in South Korea

For the registration of medicines, it is crucial to identify the category of the product, as the Regulatory approval process depends on that. Based on South Korea’s Ministry of Food and Drug Safety (MFDS), drugs are classified as follows:

  1. Drug products that do not require a safety and efficacy review– Drugs that have already been deemed safe and efficacious or are listed in the Korean and U.S. Pharmacopeia. These drugs only require an MFDS notification submission.
  2. Drug products that require a safety and efficacy review and intensive management– Drugs that require a review and approval to prevent risk factors.

Freyr experts will help you identify the appropriate category, respective Regulatory drug registration process in South Korea, and overall medicinal products Regulatory support in South Korea.

Drug Registration in South Korea

Based on the MFDS regulations, the registration of medicines in South Korea depends on the Regulatory classification of the drug product. South Korea drug registration and approval process with the Ministry of Food and Drug Safety (MFDS) looks like this:

  • For New Drugs:
    • Submit an Investigational New Drug (IND) application to the MFDS.
    • The MFDS conducts the IND application review.
    • Submit a New Drug Application (NDA) to the MFDS.
    • If the MFDS does not require supplementary data, the NDA is approved.
  • Prepare the application dossier for the drug approval system in Korea.
  • Submit the application to the MFDS management division for drug approval & review.
  • The MFDS conducts an initial assessment of the application, generates a report outlining the application dossier, and submits it to the MFDS Drug & Evaluation department.
  • The Drug & Evaluation department conducts a review of the following, including results of the initial assessment, technology, safety & efficacy data, product standards, clinical trial data, good manufacturing practice (GMP) data, drug master file (DMF) data, impact on intrinsic (genetic) factors, and extrinsic (factors), etc.
  • If no further documentation or supplementary data is required, the MFDS issues the applicant a Certificate of Approval.

Important Validities

The Ministry of Food and Drug Safety (MFDS) issues the Registration Certificate (RC) for five (05) years. Freyr South Korea supports you with the post-approval life cycle management of your product and with overall pharmaceutical Regulatory affairs and guide to the drug approval process in Korea.

South Korea Drug Registration and Approvals - Freyr Expertise

  • Regulatory Intelligence Support.
  • Regulatory Due Diligence Support.
  • Drug Registration Process.
  • Foreign Manufacturing Registration (FMR).
  • Marketing Authorization Holder (MAH).
  • DMAF Filing Services.
  • In-country Caretaking.
  • Good Manufacturing Practices (GMP) Conformity.
  • Submission Management to MFDS.
  • Submission Management to Notified Bodies.
  • Providing Translation Services.
  • Data Reliability Inspection.
  • Planning Timely QMS Inspections. 
  • Reimbursement Application Submission. 
  • Labeling and Artwork Support.
  • Distributor Identification and Qualification.

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