Clinical Trials Regulation (EU) No 536/2014 and CTIS

European Union, regulation. Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use applied from 31 January 2022, when the Clinical Trials Information System (CTIS) went live, and fully replaced Directive 2001/20/EC after a transition that ended on 30 January 2025. Primary text: EUR-Lex; the EMA page explains the system and the CTIS portal publishes trial records.

What it changed: one application, one set of documents and one coordinated assessment led by a reporting member state, with fixed timelines, instead of separate submissions to each national agency and ethics committee. Trial information and, twelve months after the end of a trial, a results summary and a lay summary become public by default. The regulation also sets rules for consent, including simplified consent for cluster trials, for low-intervention trials, and for co-sponsorship, and it requires adult trials to justify excluding the elderly.

Why it matters for oncology and the arguments: multinational cancer trials are the norm, and academic cooperative groups such as the EORTC had argued that the 2001 directive's national fragmentation and costs drove trials away from Europe. The regulation's rollout was slow (the portal was six years late) and sponsors complained about CTIS usability and about transparency rules exposing commercially sensitive information, which were relaxed in 2024. The ACT EU initiative aims to make Europe more attractive for trials, and the parallel GDPR rules on data still differ by country.