Guide to the Process of Approving Over-the-counter Drugs (Guide for Petitioners: Guide-1078-02)

The document provides a detailed overview of the approval process for non-prescription drugs (quasi-drugs) in South Korea, outlining the steps involved in obtaining approval for products such as mosquito and tick repellents, contact lens care products, external disinfectants, teeth whitening agents, denture and orthodontic cleaners, tooth manicure products, and toothpaste.

Key Steps in the Approval Process:

• Review of Existing Guidelines:
  • Initial step to ensure compliance with current regulatory standards for non-prescription drugs.
• Assessing Content Similarity:
  • The product’s ingredients and formulations are compared with those of existing approved products to ensure no significant differences.
• Documentation Requirements:
  • Extensive documentation is needed for safety and efficacy assessment, including:
    • Origin and Development: Information on product origin and formulation development.
    • Standards and Testing Methods: Data on testing methods and quality standards applied to the product.
    • Stability and Toxicity: Evidence of product stability over time and testing for toxicological safety.
    • Efficacy: Data supporting the product’s effectiveness in its intended use.
    • Foreign Usage: Information on the product’s approval and use in other countries.
    • Comparisons with Domestic Products: Data comparing the product with similar products already on the market in South Korea.
• Specific Product Requirements:
  • Masks and Toothpaste: Special guidelines and standards are set for specific products, ensuring they meet unique safety and efficacy criteria.
• Submission Requirements for Quasi-Drugs:
  • Detailed documentation must be provided on the product’s origin, standards, testing methods, and its comparative analysis with similar products available domestically.

This process ensures that non-prescription drugs meet regulatory, safety, and performance standards before they are approved for sale in South Korea.

Region: South Korea
Source: https://www.mfds.go.kr/brd/m_1060/view.do?seq=15584&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1