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…
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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
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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- Discovery (free): /api/v1/nodes/eu-clinical-trials-eu-ctr-trials-regulation.json — 6-field metadata
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