What does a Generic Drug refer to in the context of regulatory affairs?

In the context of regulatory affairs, a Generic Drug is defined as a medication that is produced after the patent for the original brand-name drug has expired. This means that the generic drug is formulated to be chemically identical or equivalent to the original medication in terms of dosage form, strength, route of administration, quality, and performance characteristics. Consequently, it can be marketed without conducting the full range of clinical trials that the original drug underwent, as the safety and efficacy must have already been established.

This definition is important in regulatory affairs because it emphasizes the role of patents in medication exclusivity and market competition. Once a brand-name drug's patent expires, other manufacturers can apply for approval from regulatory agencies, such as the FDA in the United States, to sell a generic version. This process involves demonstrating that the generic drug is bioequivalent to the original, ensuring that it will perform the same in the body.

Understanding this definition helps clarify the landscape of pharmaceutical products and the regulations that govern the approval and marketing of drugs after the original patent period, ultimately contributing to increased access to medications and competition in the pharmaceutical market.