What Clinical Trials in Human Medicines | European Medicines Agency (EMA) requires
All clinical trials included in marketing authorisation applications for human medicines in the EU/EEA must be conducted in accordance with Annex 1 of Directive 2001/83/EC. Trials in the EU/EEA must comply with EU clinical trial legislation, while those outside must adhere to ethical principles equivalent to those in the EEA, including international good clinical practice and the Declaration of Helsinki.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Medicines Agency (EMA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines
SHA-256 integrity: 80979331abbc6532e4807b572fd20344a64c5e46917e41680319ddd3bde48ed7
Primary Citations — 5 traced to source
- Directive 2001/83/EC, Annex 1 - Principles of Good Clinical Practice
- Clinical Trials Regulation - Requirement for trials to comply with ethical principles equivalent to those in the EEA, including Declaration of Helsinki
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