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South Korea Drug 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

Drugs are classified into two categories:

1.Prescription Drugs:

  • Used under professional diagnosis, instructions, and supervision due to:
    • Pharmacological action or indications (serious effects)
    • Administration route (e.g., injections)
    • Dosage regimen complexity
    • High risk of adverse reactions
    • Habituation/dependence potential
    • Development of resistance
    • Significant drug interactions
    • Belonging to specific categories (narcotics, psychotropics, etc.)
    • Social misuse/abuse concerns
    • New drugs not yet established
  • Examples: antibiotics, pain medications, some antidepressants

    2.Over-the-Counter Drugs:
  • Do not meet the criteria for prescription drugs
  • Generally considered safe for self-administration without professional supervision
  • Examples: pain relievers, allergy medications, cough syrups

 

The provided text outlines requirements and guidelines for the preparation of pharmaceutical approval or notification applications. Let’s break down the key points and provide detailed information:

General Application Preparation Guidelines:

(1) Document Submission:

  • Applications for manufacturing and marketing approval or notification of pharmaceuticals and importing approval or notification should be prepared based on specified documents.
  • Electronic recording media (e.g., CD, disk) with specific programs designated by the Ministry of Food and Drug Safety should be attached.
  • If a tenant medical R&D institute applies in accordance with special acts, the application form may be in English.

(2) Source Data:

  • Include source data related to prescription, efficacy, effectiveness, usage, dosage, and cautions for use.
  • Attach approval data for the same item in Korea and abroad, public reassessment results, and documents on “Standard Manufacturing Practices of Pharmaceuticals.”

For items falling under Article 5 (1) of the “Regulation on Safety of Pharmaceuticals,” specific documents regarding active ingredients, dosage form, and specifications must be attached.

 

(3) Parameter Adjustments:

  • In cases where pharmaceutical approval and notification parameters are adjusted, describe the drug based on the adjusted parameters.
  • Safety and efficacy data attachments or a pre-review letter may be required in some cases.

(4) Nonconformity in GMP:

  • For products from manufacturers with GMP nonconformity, submit details about the product, drug substance, manufacturer’s name, location, and a certificate of manufacture proving legal manufacturing. 

(5) Certificate of Manufacture:

  • If unable to submit the certificate when filing, applicants can provide a due date and submit it within the deadline.
  • The certificate of manufacture must be issued within 2 years from the submission date.

(6) Pharmaceutical Equivalence Test Data:

  • For items requiring pharmaceutical equivalence test data, prepare data according to the “Specifications for Pharmaceutical Equivalence Tests” outlined by MFDS.

(7) Foreign Data:

  • Submit a summary in Korean and original texts for foreign data, especially safety and efficacy data.
  • Complete translations may be requested if necessary.

(8) Design Space:

  • If applicable to pharmaceutical manufacturing and quality control, include Design Space information in authorization applications.

Submission Requirements:

(1) Mandatory Data Types:

  • Data related to origin, discovery, developmental history, structural and physicochemical characteristics, manufacturing methods, specification and test methods, source data, test results, reference standards, containers, packaging, stability, toxicity, pharmacological actions, clinical study results, foreign usage status, and comparative reviews.

(2) Specific Data Scope:

    • The scope of data submission depends on the properties of each pharmaceutical.

Specific Data Scope Depending on Pharmaceutical Properties:

(a) Data for Drug Substances:

  1. Structures: Provide data for defined structures.
  2. Physicochemical Characteristics: Include data on physicochemical characteristics.
  3. Manufacturing Methods: Describe the manufacturing methods.
  4. Specifications and Test Methods: Detail specifications and test methods.
  5. Source Data: Include source data for specifications and test methods.
  6. Test Results: Present data for test results.
  7. Reference Standards and Reagents: Include data for reference standards and reagents.
  8. Containers and Packaging: Provide data related to containers and packaging.

(b) Data for Finished Drug Products:

  1. Drug Substances and Quantities: Include data for drug substances and quantities.
  2. Manufacturing Methods: Detail manufacturing methods.
  3. Specifications and Test Methods: Describe specifications and test methods.
  4. Source Data: Include source data for specifications and test methods.
  5. Test Results: Provide data for test results.
  6. Reference Standards and Reagents: Include data for reference standards and reagents.
  7. Containers and Packaging: Include relevant data.

(c) Data for Stability:

  1. Drug Substances: Include long-term and accelerated test data.
  2. Finished Drug Products: Provide long-term and accelerated test data.

(d) Data for Toxicity:

  1. Single Dose Toxicity Study: Include data.
  2. Repeat Dose Toxicity Study: Provide relevant data.
  3. Genotoxicity Study: Include genotoxicity study data.
  4. Reproductive and Developmental Toxicity Study: Present relevant data.
  5. Carcinogenicity Study: Include carcinogenicity study data.
  6. Other Toxicity Studies: Include various toxicity study data.

(e) Data for Pharmacological Actions:

  1. Efficacy Study: Include efficacy study data.
  2. General Pharmacology or Safety Pharmacology Study: Provide relevant data.
  3. Absorption, Distribution, Metabolism, and Excretion Study: Include analytical methods, validation reports, and relevant data.
  4. Drug-to-Drug Interactions: Include relevant data.

(f) Data for Clinical Study Results:

  1. Investigator’s Brochure (IB): Include biopharmaceutical study reports, PK-related study reports, PK study reports, PD study reports, efficacy and safety study reports, post-marketing surveillance reports, CRF, and individual patient lists.
  2. Bridging Data: Provide relevant data.
  3. Bioequivalence Test Data: Include data for bioequivalence tests.

(g) Data for Foreign Usage Status:

Provide relevant data on the foreign usage status of the pharmaceutical.

(h) Data for Comparative Review:

Include data comparing the pharmaceutical with similar domestic products and properties of relevant drugs.

Ensure compliance with all requirements outlined in the “Regulation on Safety of Pharmaceuticals, Etc.” and other relevant regulations during the preparation and submission of the pharmaceutical approval or notification applications. Adhering to these guidelines is essential for a thorough and successful review process.

A Comprehensive Guide to New Drug Approval:

Introduction

Article 6, in spite of Article 5, mandates the preparation of CTDs for new drugs, drugs requiring data submission, and drugs falling under Article 25. This includes prescription drugs, excluding orphan drugs, high-pressure gases for medical use, radiopharmaceuticals, drugs for export, and other products not directly applied to humans.

Detailed Preparation Tips: Annex 3 and Beyond

For drugs falling under the specified categories, detailed preparation tips are governed by Annex 3 the Preparation Method for Drugs CTD. It is imperative to adhere to these guidelines to ensure a smooth submission process. Additionally, for items beyond the specified categories, the CTD format remains mandatory, emphasizing the importance of a standardized documentation approach.

Electronic Submission and Data Standards

The pharmaceutical approval application or notification, as per Articles 4 and 6, may be submitted as electronic documents. This is facilitated when the Minister of the Ministry of Food and Drug Safety notifies eCTD preparation tips. In such cases, nonclinical study data and clinical study data can be submitted by applying the Clinical Data Interchange Standards Consortium.

Module 1: Administrative Information and Prescribing Information

1.1 Table of Contents of Module 1

A well-organized table of contents serves as the roadmap for the entire submission, ensuring clarity and accessibility.

1.2 Copy of Manufacturing and Marketing Approval

In this section, include the manufacturing and marketing approval details or notification application, providing a comprehensive overview.

1.3 Information and Signature Data

Details about the person in charge of collection and preparation work are crucial, ensuring accountability and transparency in the application process.

1.4 Translation Information

For foreign data, include statement and signature data of the translator to maintain accuracy and consistency in the documentation.

1.5 Foreign Usage Status

Data regarding foreign usage status adds a global perspective, contributing to a holistic assessment of the drug.

1.6 Comparative Data

Include data for comparative analysis with similar domestic products, shedding light on the uniqueness and efficacy of the new drug.

1.7 Submitted Data in Accordance with Article 4 (1)

Submission of relevant data as per regulatory requirements is critical, covering various aspects such as BE test plans, comparative clinical study protocols, and dissolution test data.

1.8 Certificates and Attachments

Certificates for data use allowance, transfer, and acquisition contracts, along with other necessary attachments, must be provided where applicable.

1.9 Certificates for Nonclinical and Clinical Study Data

Ensuring the submission of certificates for nonclinical study data and clinical study data is essential for comprehensive evaluation.

1.10 Attachment (Draft)

Detailed instructions for the attachment in HWP document format provide clarity on matters to be included, ensuring completeness.

1.11 Other Relevant Information

Include any other necessary information not covered under specific subparagraphs, providing a comprehensive view of the submission.

Module 2: Common Technical Document Summaries

2.1 Table of Contents

A structured table of contents for Module 2 sets the stage for an organized presentation of essential summaries.

2.2 Quality Overall Summary (QOS)

The QOS provides a holistic overview of the drug’s quality, summarizing key quality attributes and characteristics.

2.3 Nonclinical and Clinical Overviews

In-depth overviews of nonclinical and clinical aspects offer a comprehensive understanding of the drug’s safety and efficacy.

2.4 Nonclinical Summaries

Summarized nonclinical data provides insights into the drug’s safety profile, essential for regulatory assessments.

2.5 Clinical Summaries and Bridging Data

Clinical summaries and bridging data bridge the gap between nonclinical and clinical aspects, enhancing the coherence of the submission.

Module 3: Quality

3.1 Table of Contents

A structured table of contents for Module 3 ensures easy navigation through the extensive quality-related data.

3.2 Body of Data

Detailed information on drug substances and products, with exemptions for substances already registered, contributes to a thorough quality assessment.

3.3 Literature References

Citing relevant literature references enhances the credibility of the data presented in Module 3.

Module 4: Nonclinical Study Reports

4.1 Table of Contents

An organized table of contents for Module 4 facilitates efficient access to nonclinical study reports.

4.2 Nonclinical Study Reports

Detailed reports on nonclinical studies provide crucial insights into the drug’s preclinical safety and efficacy.

4.3 Literature References

Citations of pertinent literature reinforce the scientific foundation of the nonclinical study reports.

Module 5: Clinical Study Reports

5.1 Table of Contents

A well-structured table of contents for Module 5 ensures easy navigation through extensive clinical study reports.

5.2 Tabular Listings of All Clinical Studies

Tabular listings of all clinical studies provide a quick overview of the breadth of clinical research conducted.

5.3 Clinical Study Reports

Detailed clinical study reports offer a deep dive into the methodologies, results, and conclusions of the conducted studies.

5.4 Literature References

Citing literature references in clinical study reports enhances the credibility of the presented clinical data.

Types of Submitted Data and Review Data

The types of submitted data, as per paragraph 1, align with the types of review data specified in Article 5 (1). A detailed comparison between Review Data and CTD Data Submitted, including requirements, exemption scope, etc., ensures compliance with regulatory standards.