What it is and where it stands
Regulation (EU) No 536/2014, the Clinical Trials Regulation, entered into application on 31 January 2022, repealing Directive 2001/20/EC. It created one application route through the Clinical Trials Information System (CTIS), where a single application can cover up to 30 European countries.
The transition is now complete:
- Until 30 January 2023, sponsors could choose CTIS or the old Directive route.
- From 31 January 2023, all new applications had to use CTIS.
- By 31 January 2025, trials approved under the Directive and still running had to comply with the Regulation and be recorded in CTIS.
So in 2026, every ongoing EU trial should sit under the CTR. CTIS also has a public website, part of the Regulation’s transparency goals, which matters when you decide what trial information is public and what is not.
Where to find it
- EUR-Lex: the Official Journal text of Regulation 536/2014 and its implementing and delegated acts.
- EMA’s Clinical Trials Regulation page: the overview, CTIS, and links to ACT EU reports.
- EudraLex Volume 10: clinical trial guidelines and Q&A.
Reuse terms
EUR-Lex text is reusable with attribution under Commission Decision 2011/833/EU. EMA’s legal notice allows reproduction, including commercial use, as long as EMA is acknowledged as the source in each copy. Third-party content and the EMA logo are excluded.
Our note, prefer the OJ original, reflects that only the Official Journal is authentic. Consolidated texts and EMA summaries are helpful, but should not be the cited legal basis.
Using the CTR in AI and RAG
- Index the OJ text of 536/2014 and record its ELI and CELEX.
- Add implementing acts and Volume 10 Q&A as separate layers, each with its own date and status.
- Store EMA explanatory pages as secondary sources with an EMA attribution field.
- Separate public CTIS data from your own confidential trial documents. Do not mix them in one index.
- Label pre-2023 Directive material as historical so it does not answer current-process questions.
- Re-check EMA and CTIS updates quarterly, since CTIS procedures and transparency rules evolve.
Common mistakes
- Answering CTR questions from Directive 2001/20/EC material.
- Citing an EMA summary as if it were the regulation.
- Indexing your own protocols and CTIS submissions alongside public data.
- Dropping EMA attribution in exported outputs.
Checklist
- OJ text indexed with ELI and CELEX
- Implementing acts and Volume 10 Q&A layered and dated
- EMA pages labeled secondary with attribution
- Confidential trial documents in a separate private index
- Directive-era content marked historical
- Quarterly refresh scheduled
How AskDona helps
AskDona checks protocols, informed consent templates, and CTIS submission packages against the CTR articles and annexes, and every finding cites the OJ text it used. Your trial documents stay in your private workspace.
Run a sample CTR submission check
AskDona shows the evidence; your clinical operations team decides.
Editor’s note. This article is general information, not legal advice. The “conditional use” rating comes from our source list and is a first-pass judgment, not a legal opinion.
FAQ
Is the CTR transition over? Yes. Ongoing Directive-era trials had to move to the CTR and CTIS by 31 January 2025.
Can I reuse EMA’s CTR pages in an AI tool? Yes, including commercially, if EMA is acknowledged as the source in each copy. Third-party content is excluded.
Why prefer the Official Journal text? It is the authentic legal version. Consolidated and summary texts are aids.
Is CTIS data public? CTIS has a public website for trial information. Your own submissions also contain confidential information, so manage the two separately.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| EMA: Clinical Trials Regulation (updated Aug 26, 2025) | Application 31 Jan 2022, transition dates, CTIS, transparency |
| EMA legal notice | Reproduction allowed with source acknowledged, commercial use, exclusions |
| EUR-Lex legal notice | Reuse policy, OJ authenticity |
| European Commission: EudraLex | Volume 10, clinical trial guidelines |