market authorization

Market authorization is the official approval granted by a regulatory authority, such as the FDA or EMA, allowing a pharmaceutical company to sell a specific medicine or product. It confirms that the product has undergone rigorous testing for safety, quality, and effectiveness. This approval ensures that healthcare providers and patients can trust the product meets established standards. Obtaining market authorization involves submitting detailed data and analysis, demonstrating that the product’s benefits outweigh potential risks. Essentially, it is a formal permission that confirms a medicine is suitable for public use within a specific market.