What is the Approval Process for Gynecological Drugs?
The approval process for gynecological drugs involves several stages: 1. Preclinical Research: Initial studies in the lab and on animals. 2. Clinical Trials: Multi-phase trials on human subjects to test safety, efficacy, and side effects. 3. Marketing Authorization Application (MAA): Submission of trial data to the EMA. 4. Scientific Evaluation: Comprehensive review by the EMA’s scientific committees. 5. Approval: If the data supports the drug’s safety and efficacy, the EMA grants marketing authorization.
