FDA IND vs EU CTR
Two front doors to running a clinical trial — US application vs EU regulation.
What a comparison is not
A comparison is SPEQ’s reading of how two published documents differ. Neither is the right answer, it is not a determination of which applies to you, and neither is summarised in a way that replaces reading it.
To run an interventional drug trial you need regulatory and ethics authorisation. In the US, the sponsor submits an Investigational New Drug (IND) application to the FDA under 21 CFR 312. In the EU, the Clinical Trials Regulation (536/2014) governs authorisation through a single submission via the CTIS portal, coordinated across member states. They differ in mechanism, portal, and how multi-country trials are handled.
| ASPECT | FDA IND | EU CTR |
|---|---|---|
| Instrument | IND application to the FDA (21 CFR 312) | Regulation 536/2014, via the CTIS portal |
| How approval works | 30-day default review; trial may proceed unless FDA places a hold | Coordinated assessment across member states, with a reporting member state |
| Multi-country trials | National (US); ex-US handled separately | One application covers multiple EU member states |
| Ethics review | IRB review, separate from the IND | Ethics review integrated into the CTR process/timeline |
| Transparency | ClinicalTrials.gov registration/results | CTIS provides substantial public transparency |
| Safety reporting | IND safety reports to FDA (21 CFR 312.32) | SUSAR/annual safety reporting under the CTR |
File an IND with the FDA to conduct an interventional drug trial in the US — the trial may generally begin 30 days after submission unless the FDA imposes a clinical hold.
Use the EU CTR (via CTIS) for trials in the EU/EEA — a single application can cover multiple member states through a coordinated assessment, with a defined role for the reporting member state and integrated ethics timelines.
Same goal, different machinery: an IND is a US application to one agency; the CTR is an EU regulation operated through a shared portal that coordinates many member states at once. A global programme runs both, aligning the protocol and safety reporting while respecting each system’s submission mechanics, transparency rules, and timelines. The CTR’s single-submission model is the biggest operational contrast with the country-by-country ex-US world it replaced.
FDA IND vs EU CTR: frequently asked questions
Common questions on how FDA IND and EU CTR differ and when each applies.
What is an IND?
An Investigational New Drug application is the submission a sponsor makes to the FDA under 21 CFR 312 to ship and administer an investigational drug in a US clinical trial. The trial may generally begin 30 days after submission unless the FDA places it on clinical hold.
How does the EU CTR differ from the old Clinical Trials Directive?
The Clinical Trials Regulation (536/2014) replaced the Directive with a single, harmonised authorisation process via the CTIS portal, enabling one application to cover multiple member states through a coordinated assessment — instead of separate national submissions under the Directive.
Do I need both for a global trial?
Yes. A trial running in both the US and the EU needs an IND for the US and a CTR authorisation (via CTIS) for the EU member states involved, with a harmonised protocol and aligned safety reporting across both.
How is ethics review handled?
In the US, an Institutional Review Board reviews the trial separately from the IND. Under the EU CTR, ethics committee review is integrated into the regulation’s assessment process and timelines, coordinated with the regulatory assessment.