The Clinical Trials Regulation, Regulation (EU) No 536/2014, harmonises how clinical trials of medicinal products are authorised and supervised across the European Union. It applied from 31 January 2022, replacing the earlier Clinical Trials Directive, and introduced a single entry point called the Clinical Trials Information System (CTIS). Through CTIS a sponsor submits one application for a trial that may run in several member states, and the member states carry out a coordinated assessment. The regulation strengthened transparency, with much trial information made public, and set common rules on safety reporting and inspections. Good Clinical Practice, the international quality standard for designing, conducting, and reporting trials, continues to apply. A transition period required all ongoing trials to move to the new framework.
What is the EU Clinical Trials Regulation?
The EU Clinical Trials Regulation (EU) No 536/2014 harmonises the authorisation and oversight of clinical trials across the EU through a single portal.
What is CTIS?
CTIS, the Clinical Trials Information System, is the single EU portal and database used to apply for, assess, and supervise clinical trials under the Clinical Trials Regulation.
Implementation of the Clinical Trials Regulation
ACT EU - Accelerating Clinical TrialsPMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – July 2026
23 Jul 2026 PMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – July 2026 Online Start date: 23 July 2026, 09:30 (CEST) End date: 23 July 2026, 10:30 (CEST)
EMA - European Medicines AgencyAMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.953v01-00
AMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...
European Parliament - SANT Subcommittee (Public Health)AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.939v01-00
AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...
European Parliament - SANT Subcommittee (Public Health)Clinical trials for medicines: Clinical Trials Regulations transitional arrangements
Guidance on transitional arrangements for the Clinical Trials Regulations.
UK MHRAPsychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Psychedelic Drugs: Considerations for Clinical Investigations." Because interest in the therapeu...
US Federal Register - FDA Guidance NoticesQuestions and answers (version 22) - Safety features for medicinal products for human use
News announcement 10 July 2026 Questions and answers (version 22) - Safety features for medicinal products for human use 1 min read
EC Public Health