Clinical Trials Regulation (CTR)
The EU Clinical Trials Regulation, which replaced Directive 2001/20/EC and harmonised the assessment and supervision of clinical trials across the EU/EEA through a single application submitted via the Clinical Trials Information System (CTIS). It introduces a coordinated assessment led by a Reporting Member State and increased transparency of trial information.
Interventional clinical trials of medicinal products conducted in the EU/EEA. Since 31 January 2023 all new trials must be submitted under the CTR via CTIS; the transition of legacy Directive trials completed by 31 January 2025.
- 01Submit a single application via CTIS for authorisation across all concerned Member States
- 02Comply with the coordinated assessment timelines led by the Reporting Member State
- 03Report SUSARs and submit annual safety reports as required
- 04Meet CTIS transparency and document-publication obligations (with limited deferrals)
Entered into application 31 January 2022, replacing Directive 2001/20/EC. Mandatory for new trials from 31 January 2023; legacy trials transitioned by 31 January 2025.
Regulation (EU) 536/2014: frequently asked questions
Quick answers to common questions about Regulation (EU) 536/2014.
What is Regulation (EU) 536/2014?
Regulation (EU) 536/2014 — Clinical Trials Regulation (CTR) — is a regulation issued by the European Medicines Agency (European Union). The EU Clinical Trials Regulation, which replaced Directive 2001/20/EC and harmonised the assessment and supervision of clinical trials across the EU/EEA through a single application submitted via the Clinical Trials Information System (CTIS). It introduces a coordinated assessment led by a Reporting Member State and increased transparency of trial information.
Who does Regulation (EU) 536/2014 apply to?
Interventional clinical trials of medicinal products conducted in the EU/EEA. Since 31 January 2023 all new trials must be submitted under the CTR via CTIS; the transition of legacy Directive trials completed by 31 January 2025.
What are the key requirements of Regulation (EU) 536/2014?
EMA Regulation (EU) 536/2014 requires, among other things: Submit a single application via CTIS for authorisation across all concerned Member States; Comply with the coordinated assessment timelines led by the Reporting Member State; Report SUSARs and submit annual safety reports as required; Meet CTIS transparency and document-publication obligations (with limited deferrals).
When was Regulation (EU) 536/2014 last updated?
The current version of Regulation (EU) 536/2014 dates from January 2022. Entered into application 31 January 2022, replacing Directive 2001/20/EC. Mandatory for new trials from 31 January 2023; legacy trials transitioned by 31 January 2025.
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