Quasi Drugs: Regulatory & Commercial Considerations for Japan and South Korea

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Navigating Quasi-Drug Regulations and Market Entry in Japan and South Korea

In the dynamic Asia-Pacific market, quasi drugs represent a unique regulatory category that bridges the gap between cosmetics and pharmaceuticals. Particularly in Japan and South Korea, quasi drugs have gained traction for their hybrid benefits offering therapeutic claims while maintaining a relatively simpler regulatory pathway compared to full-fledged drugs. 

 

Quasi Drugs: Regulatory & Commercial Considerations for Japan and South Korea

Understanding the regulatory and commercial landscape of quasi drugs in these two key markets is essential for global companies aiming to enter or expand in East Asia. This article explores the updated guidelines, approval requirements, and commercialization opportunities for quasi drugs in Japan and South Korea. 


What Are Quasi Drugs?

Quasi drugs are defined as products that have mild pharmacological effects or physiological functions. They may not be as potent as traditional drugs, but they go beyond the scope of general cosmetics. These products can include: 

 

  • Medicated shampoos 

  • Hair growth tonics 

  • Anti-acne treatments 

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