What EU Clinical Trials Regulation 2014/536 - Clinical Trial Authorisation, CTIS, and Informed Consent requires
Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use replaced Directive 2001/20/EC and became applicable from 31 January 2022. The Regulation establishes a single EU-wide authorisation procedure for clinical trials conducted in one or more Member States via the Clinical Trials Information System (CTIS). Article 5 requires sponsors to submit a single clinical trial application (CTA) via CTIS covering all participating Member States. The assessment is divided into Part I (scientific and technical assessment coordinated by the reporting Member State) and Part II (ethical and national compliance assessment conducted by each Member State individually). Sponsors may not start a clinical trial until they receive combined authorisation under Article 8. Articles 28 to 35 govern informed consent requirements including specific protections for vulnerable populations (children, incapacitated adults, emergency situations). Article 41 requires reporting of all adverse events to the EMA EudraVigilance database. The CTIS portal (managed by the EMA) is the single entry point for CTA submissions, authorisation decisions, modifications, and safety reporting. The Regulation introduces transparency obligations including mandatory public disclosure of clinical trial results in the EU Clinical Trials Register within 12 months of the end of the trial.
Pillar: Biotech & Genomics · Authority: European Medicines Agency (EMA); national competent authorities; ethics committees · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0536
SHA-256 integrity: 3574de944845444ab5ec4520aace7eed1db4f67da32ee6373378a5c26ca739cf
Primary Citations — 7 traced to source
- Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - OJ L 158/1, 27.5.2014; applicable from 31 January 2022; replaces Directive 2001/20/EC
- Regulation 536/2014 Article 5 - single CTA via CTIS covering all Member States; Part I (scientific) and Part II (national/ethical) assessment structure
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