What EU Clinical Trials Regulation 536/2014 (CTR) - Investigational Medicinal Products and Trial Authorisation requires
Regulation (EU) No 536/2014 establishes a harmonised EU-wide authorisation procedure for clinical trials on investigational medicinal products via the Clinical Trials Information System (CTIS)…
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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-development/clinical-trials-human-medicines
SHA-256 integrity: d4e5191e408191d72d73171fdbea4c128596de54650fced7840d1b964337dd3d
Primary Citations — 5 traced to source
- Article 5 (submission), Article 41 (SAE reporting), Article 37 (results) — Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use
- Sponsor registration and submission procedures — EMA Clinical Trials Information System (CTIS) guidance
+ 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-regulation-536-2014-ctr-investigational-medicinal-products.json — 6-field metadata
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