How do the FDA and the European Medicines Agency review new drugs before approval?

The Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in the European Union both utilize rigorous, science-based review processes to ensure that new drugs maintain a favorable risk-to-benefit ratio before reaching the market.12

The Review Process

Both agencies rely on data derived from preclinical studies in animals and a structured sequence of clinical trials in humans. These trials are categorized into phases to systematically evaluate safety and efficacy:12
* Phase 1: Establishes safe dosage and monitors initial human tolerance.2
* Phase 2: Assesses the drug's effectiveness for a specific medical condition in a larger group.2
* Phase 3: Compares the new intervention against standard treatments or a placebo to confirm therapeutic benefits and identify potential side effects.2

Regulatory Documentation

In the U.S., companies submit a New Drug Application (NDA), a comprehensive report detailing chemistry, manufacturing, animal pharmacology, and clinical trial results. The FDA and the manufacturer then negotiate the drug's official labeling, which dictates the legal claims regarding safety and efficacy. The EMA conducts a similar review of clinical data to determine if a drug meets the standards for approval within the European Union.32

To improve efficiency, regulatory authorities often collaborate through the International Conference on Harmonisation to align technical requirements and reduce redundant testing.12