DDReg Pharma- Consulting in regulatory affairs and drug safety

  Biosimilars are biologic products highly similar to an already approved reference product, with no clinically meaningful differences in safety, purity, or potency. Unlike generic drugs, biosimilars involve intricate manufacturing processes due to the complexity of their molecular structures and the living systems used in their production. Given their potential to reduce healthcare costs and increase patient access, regulatory authorities in the EU and US have established specific pathways to ensure the safety, efficacy, and quality of these products. Read more about different pathways here:  https://resource.ddregpharma.com/blogs/a-complete-guide-to-regulatory-pathways-for-biosimilars-in-the-eu-and-us/ Contact us today to fastrack your product in the market:  https://resource.ddregpharma.com/blogs/a-complete-guide-to-regulatory-pathways-for-biosimilars-in-the-eu-and-us/

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/