REGULATION
Regulation (EU) No 536/2014 on Clinical Trials on Medicinal Products for Human Use
ABSTRACT — EDITORS' SUMMARY
The EU statutory framework for clinical trials, replacing Directive 2001/20/EC. Sponsor obligations, ethics review, safety reporting, transparency requirements. All EU trials must comply via CTIS since January 2023.
STATUTE · CANONICAL SOURCE
Read on canonical statute source eur-lex.europa.eu ↗ METADATA
SOURCE
LINK · CANONICAL LINK https://eur-lex.europa.eu/eli/reg/2014/536/oj/eng ↗ RELATED · SAME AUTHORITY