What EU Clinical Trials Regulation 2014/536 - Authorisation and Conduct of Clinical Trials for Investigational Medicinal Products requires
Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR) replaced Directive 2001/20/EC and establishes a harmonised procedure for clinical trial authorisation across the EU via the Clinical Trials Information System (CTIS). Sponsors must obtain Ethics Committee and Member State authority approval; apply consistent GCP standards; report serious adverse events; and register trials on the EU Clinical Trials Register.
Pillar: Pharmaceuticals & Life Sciences · Authority: EUR-Lex - Official Journal of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R0536
SHA-256 integrity: 827230e2ca085f89036e62623bed5ae8f0ef63b0aa2dd8e129e1640d5738c58e
Primary Citations — 5 traced to source
- {"title":"Regulation (EU) No 536/2014 - Clinical Trials Regulation (CTR)","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R0536","section":"Arts. 5-10, 25, 42, 43, 63 - CTIS Submission, Assessment, Registration, SUSARs, DSUR, GMP"}
- {"title":"ICH E6(R3) - Good Clinical Practice Guideline","url":"https://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html","section":"GCP principles; investigator, sponsor, and monitor responsibilities"}
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