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

The document provides a comprehensive overview of the quasi-drug approval process in South Korea, detailing the requirements, procedures, and guidelines for applicants. It addresses the evaluation and approval of products such as:

• Mosquito repellents
• Contact lens care products
• External disinfectants
• Teeth whitening agents
• Denture and orthodontic cleaners
• Tooth manicure products
• Toothpaste

Key elements of the approval process include submission of documentation covering the product’s origin, development, standards, testing methods, stability, toxicity, efficacy, foreign usage, and comparisons with similar domestic products. Specific guidelines are provided for products like masks and toothpaste.

The document also includes detailed instructions for quasi-drug submissions, including:

• Standards and testing methods
• Product origin and development data
• Comparisons with similar products

Additionally, it offers manuals and guidelines for preparing product names, usage precautions, and FAQs related to sanitary products such as sanitary pads and cups. The information is intended for guidance purposes only and does not have legal enforceability.

Region: South Korea
Source: https://www.mfds.go.kr/brd/m_1060/down.do?brd_id=data0011&seq=15584&data_tp=A&file_seq=1