In South Korea, a regulatory category known as "quasi-drugs" plays an important role in the beauty and personal care sector. Falling between cosmetics and pharmaceuticals, quasi-drugs include products such as antiperspirants, hair growth treatments, anti-acne agents, etc. Their dual nature means they are subject to stricter oversight than cosmetics while not being regulated as rigorously as drugs. Understanding how quasi-drugs are defined and managed is essential for companies aiming to expand into the Korean beauty market.
This webinar will provide a comprehensive overview of Korea's regulatory framework for beauty products classified as quasi-drugs. Speaker Mike Sohn will cover legal definitions, key regulatory authorities, and the approval process, including required documents and efficacy data, as well as labeling and advertising compliance, common pitfalls in marketing claims, and practical considerations for importation and distribution.
I. Introduction to Quasi-Drugs in South Korea
Definition of "Quasi-Drugs" under the Pharmaceutical Affairs Act
Differences between quasi-drugs, cosmetics, and drugs
Beauty product categories classified as quasi-drugs (e.g., antiperspirants, hair growth products, anti-acne agents, etc.)
II. Regulatory Authorities and Legal Framework
III. Product Registration and Approval Process
Pre-market approval requirements
Key documents required for submission
Clinical or efficacy data requirements
Review timelines and approval validity
IV. Labeling and Advertising Compliance
Mandatory labeling components for quasi-drugs
Claim limitations and acceptable language
Common advertising violations
V. Importation and Distribution Considerations
Requirements for overseas companies (including designating a local agent/responsible seller)
Import documentation and clearance procedures
Distribution channel compliance
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