Breaking Into the South Korean Pharma Market: A Regulatory Roadmap


South Korea has a structured system for classifying pharmaceuticals, determining regulatory requirements and approval pathways. This classification system categorizes pharmaceutical products and their ingredients; further, these drug products can be divided into three categories. Firstly, new drugs, as defined by unique chemical structures or original composition, require extensive clinical and non-clinical data in order to demonstrate safety and efficacy. Second, Certain pharmaceuticals with improved efficacy or novel active ingredient compositions require additional data submission. Thirdly, generics, which are bioequivalents of reference drugs. Their classification system serves as a framework that determines which level of documentation and tests will be needed in order to obtain regulatory approval. 

Read more: https://resource.ddregpharma.com/blogs/navigating-the-drug-regulatory-landscape-of-south-korea/

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