Clinical Trials Regulation

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Stage: In force
In force: In force since 16 Jun 2014 · CELEX 32014R0536
Procedure: Regulation
Last activity: 16 Apr 2014

3 acts

Delegated and implementing acts beneath it

By status: 3 published.

Act	Kind	Status	Adoption
Commission Implementing Regulation (EU) 2021/982	Delegated · Regulation	Published	Q2 2022
Commission Delegated Regulation (EU) 2016/861	Implementing · Regulation	Published	Q4 2021
Commission Delegated Regulation (EU) 2017/1569	Delegated · Regulation	Published	23/05/2017

Titles link to EUR-Lex where the act has been published.

Summary

Generated

Regulation (EU) 536/2014 governs all clinical trials on medicinal products in the EU, replacing Directive 2001/20/EC. It introduces a single application through an EU portal with a coordinated assessment by a reporting Member State. Applies from six months after the Commission's functionality notice, but no earlier than 28 May 2016. In force now.

What the workspace adds on this file

Everything above is the public record. Subscribers see this page with their own layer on top.

Why it matters to you

What this file means for your organization, assessed against your own priorities.

What moved

When this file moves, it reaches your own briefing, with a link to its source.

Your contacts on it

Your team's contacts logged against this file: who you met, what was said and the next step.

A first draft

A statement, a member update or a meeting brief on this file, in your organization's voice, with its sources.

Sources: EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

Request access

See this file with your own layer on top: why it matters to you, your contacts on it and a first draft. We’ll schedule a 20-minute walkthrough.

EU-hosted · GDPR-compliant · Trust Center →

By submitting, you agree to our privacy policy.