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Korean Ministry of Food and Drug Safety (MFDS) Approval Processes

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Korean Ministry of Food and Drug Safety (MFDS) Approval Processes

Regulatory Authority:

Ministry of Food and Drug Safety (MFDS)

Link for Regulatory Authority:

https://www.mfds.go.kr/eng/index.do

Local Authorised:

Yes

Registration Timeline:

12 to 24 months

Registration Fee:

₩3,000,000 (~$2,400)

License Validity:

5 Years

Biopharmaceuticals Policy Division:

  • Function: Establishes and revises policies for biologics, supports sponsors, and is involved in international cooperation.
  • Key Activities:
    • Develops and implements policies related to the development, manufacturing, and marketing of biologics.
    • Provides guidance and support to sponsors of biologics applications.
    • Represents Korea in international forums on biologics regulation.

Biopharmaceuticals Quality Management Division:

  • Function: Oversees the quality and safety of biologics throughout their lifecycle.
  • Key Activities:
    • Conducts inspections of biologics manufacturing facilities to ensure compliance with Good Manufacturing Practice (GMP) regulations.
    • Reviews and approves the quality and safety of biologics products.
    • Manages a system for tracking and reporting adverse events associated with biologics.

Biologics Division:

  • Function: Evaluates the safety and efficacy of biologics for marketing authorization.
  • Key Activities:
    • Reviews the CMC (Chemistry, Manufacturing, and Controls) section of biologics applications.
    • Reviews the pharmacology, toxicology, and clinical data sections of biologics applications.
    • Provides scientific advice to sponsors of biologics applications.

National Center for Lot Release:

  • Function: Conducts official lot release testing of biologics.
  • Key Activities:
    • Performs tests to ensure that each batch of a biologic product meets its specifications.
    • Issues certificates of analysis for biologics products.
    • Conducts research on new testing methods for biologics.

Other Units:

  • Biopharmaceuticals Division, including the Biologics Research Unit, the Vaccine Evaluation Unit, and the International Cooperation Unit. These units play important roles in supporting the core functions of the division.

Overall, the Biopharmaceuticals Division is responsible for ensuring the safety, efficacy, and quality of biologics in Korea. The division’s work is essential for protecting public health and promoting innovation in the biologics industry.

Approval Process:

Preclinical Development:

  • This is the initial stage of drug development, where researchers conduct laboratory and animal studies to assess the safety and efficacy of a new drug candidate.
  • The goal of this stage is to gather enough data to support the submission of an Investigational New Drug (IND) application to the regulatory agency (MFDS in this case).

Pre-IND Meeting (Optional):

  • This is an optional meeting between the drug developer and the MFDS to discuss the IND application and any potential issues.

30 days MFDS Review for IND Approval:

  • After the IND application is submitted, the MFDS has 30 days to review it and decide whether to approve it.
  • If the IND is approved, the drug developer can then begin Phase I clinical trials.

Phase I, II, III Clinical Trials:

  • These are the three phases of clinical trials in humans.
  • Phase I: This is a small study, typically involving 20-100 healthy volunteers, to assess the safety of the drug and determine the safe dosage range.
  • Phase II: This is a larger study, typically involving 100-300 patients with the target disease or condition, to further evaluate the safety and efficacy of the drug and identify the most effective dose.
  • Phase III: This is a large-scale study, typically involving hundreds or even thousands of patients, to confirm the safety and efficacy of the drug and compare it to existing treatments.

Dossier Review for Quality, Safety & Efficacy:

  • Throughout the clinical trial process, the MFDS will review the data collected to ensure that the drug is safe and effective.

Protocol Review:

  • The MFDS will also review the study protocol to ensure that it is well-designed and meets all ethical and regulatory requirements.

Pre-NDA Meeting (Optional):

  • Similar to the Pre-IND meeting, this is an optional meeting between the drug developer and the MFDS to discuss the New Drug Application (NDA) before it is submitted.

115 days MFDS Review for NDA Approval:

  • After the NDA is submitted, the MFDS has 115 days to review it and decide whether to approve the drug for marketing.

NDA Approval:

  • If the NDA is approved, the drug can be marketed in South Korea.

Additionalsteps:

  • Pre-approval GMP inspection: The MFDS may inspect the manufacturing facilities of the drug to ensure that they meet Good Manufacturing Practice (GMP) standards.
  • Product QC testing: The drug product will be tested to ensure that it meets quality control standards.

Clinical Trial Management Division of the MFDS:

Step 1: Submit an IND application

  • The applicant, which could be a pharmaceutical company, research institution, or individual researcher, submits an Investigational New Drug (IND) application to the MFDS.
  • The IND application should contain a detailed plan for the clinical trial, including information about the drug, the study design, the investigators, and the patients.
  • The MFDS will review the IND application to ensure that it meets all regulatory requirements and that the proposed study is safe and ethical.

Step 2: CMC Review

  • Once the IND application is accepted, the MFDS will begin its review. The first step is a review of the Chemistry, Manufacturing, and Controls (CMC) section of the application.
  • This review will assess whether the drug has been manufactured according to Good Manufacturing Practice (GMP) standards and whether the quality control procedures are adequate.

Step 3: Stability Review

  • While the CMC review is ongoing, the MFDS will also conduct a stability review of the drug product.
  • This review will assess how the drug product changes over time under different storage conditions.

Step 4: Pharm/Tox Review

  • After the CMC and stability reviews are completed, the MFDS will begin its review of the pharmacological and toxicological data in the IND application.
  • This review will assess the safety and efficacy of the drug in animals.

Step 5: Clinical Data Review

  • Once the Pharm/Tox review is completed, the MFDS will begin its review of the clinical data in the IND application.
  • This review will assess the safety and efficacy of the drug in humans.

Step 6: Biologics Division Review (if applicable)

  • If the drug is a biologic, such as a vaccine or gene therapy, the IND application will also be reviewed by the Biologics Division.
  • The Biologics Division will assess the safety and efficacy of the drug in the context of its biological properties.

Step 7: Complete and Acceptable?

  • After all of the reviews are completed, the MFDS will determine whether the IND application is complete and acceptable.
  • If the application is complete and acceptable, the MFDS will issue a Notice of Approval to the applicant.

Step 8: 30 days Clinical Hold or Review Requested

  • If the MFDS has any questions about the IND application, they may place the application on clinical hold.
  • This means that the clinical trial cannot begin until the MFDS’s questions are addressed.
  • The MFDS may also request additional information from the applicant.

Step 9: Additional Info Requested

  • If the MFDS requests additional information from the applicant, the applicant must submit the information within the requested timeframe.
  • Once the MFDS has received the additional information, they will continue their review of the IND application.

Step 10: Objection or Yes

  • After reviewing the additional information, the MFDS may either raise an objection to the IND application or approve it.
  • If the MFDS raises an objection, the applicant has the opportunity to respond to the objection.
  • If the MFDS approves the IND application, the applicant can begin the clinical trial.

Step 11: Notify Applicant

  • Once a decision has been made on the IND application, the MFDS will notify the applicant.

Step 12: Study Ongoing or Study Completion

  • If the IND application is approved, the clinical trial can begin.
  • The MFDS will monitor the clinical trial to ensure that it is being conducted safely and ethically.
  • Once the clinical trial is completed, the applicant will submit a New Drug Application (NDA) to the MFDS.

Step 13: Inspection

  • Before approving the NDA, the MFDS may conduct an inspection of the manufacturing facilities of the drug product.
  • This inspection will ensure that the drug is being manufactured according to GMP standards.

Step 14: Study completion and Inspection

  • Based on the results of the clinical trial and the inspection, the MFDS will decide whether to approve the NDA.
  • If the NDA is approved, the drug can be marketed in Korea.

The process for submitting an application for a biological product to the Korean Ministry of Food and Drug Safety (MFDS):

Preparation and Submission:

  1. Pre-BLA Meeting (Optional): Discuss your BLA with the MFDS to get feedback and guidance.
  2. BLA Submission:Submit the BLA dossier, including the following documents:
    • Common Technical Document (CTD): This standardized format organizes all technical information about the biologic product, including:
      • Module 1: Administrative Information and Labelling: Product name, dosage form, ingredients, intended use, labelling information.
      • Module 2: Summaries of Quality, Safety, and Efficacy: Concise summaries of the relevant data.
      • Module 3: Quality: Detailed information on manufacturing, testing, and quality control of the biologic product.
      • Module 4: Safety: Non-clinical and clinical safety data, including toxicology and adverse event reports.
      • Module 5: Efficacy: Clinical efficacy data from studies supporting the proposed indications and dosage.
    • Other Supporting Documents: Chemistry, Manufacturing, and Controls (CMC) data, stability data, environmental impact assessment, etc.

Review and Approval:

  1. Preliminary Review: The MFDS checks for completeness and administrative compliance of the BLA dossier.
  2. Scientific Review: The MFDS conducts a thorough review of the CTD and supporting documents, focusing on:
    • Quality: Assessing manufacturing processes, quality control procedures, and product stability.
    • Safety: Evaluating non-clinical and clinical safety data to identify potential risks and ensure patient safety.
    • Efficacy: Analysing clinical efficacy data to confirm the biologic product’s effectiveness for the proposed indications and dosage.
  3. Communication and Inspection: The MFDS may request additional information or clarifications from the applicant and may conduct on-site inspections of manufacturing facilities.
  4. BLA Approval or Rejection: Based on the review, the MFDS issues a decision to either approve or reject the BLA.

Additional Points:

  • The BLA review process typically takes 180 days but may be shorter for priority drugs or fast-track applications.
  • Bridging data from foreign clinical trials may be accepted if it meets certain criteria.
  • The BLA process may involve interactions with other Korean government agencies, such as the Korean Intellectual Property Office (KIPO).

Documents Required:

  • Specific documents related to the BLA process:
    • Drug Substance: Data on the physical, chemical, and biological properties of the biologic product itself.
    • Drug Product: Data on the finished form of the biologic product, including its formulation and packaging.
    • Clinical Data Package: A compilation of all clinical data from studies supporting the BLA.
    • Bridging Data: Data from clinical trials conducted outside of Korea that may be used to support the BLA.
    • Stability Test Data: Data on how the biologic product degrades over time under different storage conditions.
    • Toxicity Data: Data on the potential harmful effects of the biologic product in animals and humans.
    • Efficacy Studies Data: Data on the effectiveness of the biologic product in treating or preventing a specific disease.
    • Safety or General Pharmacology Studies Data: Data on the general effects of the biologic product on the body, including its mechanism of action.