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

Source: https://onco.cc/terms/eu-clinical-trials-regulation/  
OnCo record `eu-clinical-trials-regulation` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The EU rule, in force since January 2022, under which a cancer trial is submitted once through a single portal for all the countries it will run in, with results made public, replacing a 2001 directive that made every country's approval separate.

## Summary

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.

## Fields

- Kind: Term
- Last checked: 2026-09-17
- Also known as: Clinical Trials Regulation; Regulation 536/2014; CTR; CTIS; Clinical Trials Information System; Clinical Trials Directive; Directive 2001/20/EC; ACT EU
- Tags: law; eu

## Sources

- EUR-Lex: Regulation (EU) No 536/2014: https://eur-lex.europa.eu/eli/reg/2014/536/oj
- EMA: the Clinical Trials Regulation: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-regulation
- CTIS public portal: https://euclinicaltrials.eu/

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- terms: [China Human Genetic Resources rules (2019, 2023)](https://onco.cc/terms/china-hgr-rules/), [Clinical trial](https://onco.cc/terms/clinical-trial/), [Declaration of Helsinki](https://onco.cc/terms/declaration-of-helsinki/), [European Health Data Space Regulation (EU) 2025/327](https://onco.cc/terms/european-health-data-space/), [GDPR and health data (Regulation (EU) 2016/679)](https://onco.cc/terms/gdpr/), [ICH good clinical practice (E6)](https://onco.cc/terms/ich-gcp/), [Medicines and Medical Devices Act 2021](https://onco.cc/terms/medicines-medical-devices-act-2021/), [PIPL (China Personal Information Protection Law 2021)](https://onco.cc/terms/pipl/), [Regulation (EC) No 726/2004: the EU centralised procedure](https://onco.cc/terms/eu-regulation-726-2004/), [The Common Rule (45 CFR 46)](https://onco.cc/terms/common-rule/)
- technologies: [Decentralised and hybrid clinical trials](https://onco.cc/technologies/decentralised-clinical-trials/)
- institutions: [European Medicines Agency](https://onco.cc/institutions/ema/)
- bottlenecks: [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)

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