What are the Regulatory Requirements for Generic Drugs?
Regulatory bodies like the U.S. FDA and the European Medicines Agency (EMA) have stringent criteria for approving generic drugs. These drugs must demonstrate bioequivalence to the original branded drug, meaning they must have the same active ingredients, strength, dosage form, and route of administration. They must also prove they perform similarly to the original drug in terms of safety, efficacy, and quality.
