the EU Clinical Trials Regulation, a trial application can be authorised in about 60 days: 10 days for validation, 45 days for assessment of Parts I and II, and 5 days for the decision. With requests for information, the regulation allows up to 106 days. Yet an industry presentation to the EU's Accelerating Clinical Trials initiative in September 2025 reported that EU approvals were taking more than 110 days (ACT EU, EuropaBio presentation).
Since 31 January 2025, every ongoing EU trial has been under the CTR and in CTIS, so these timelines now apply to every European study. Much of the gap between 60 and 110 days sits with the sponsor, in dossier completeness, Part II documents and how quickly requests for information are answered.
The CTR clock
|
Phase
|
Standard timeline
|
With RFIs
|
|
Validation
|
10 days
|
Up to 15 more days (10 for sponsor response, 5 for decision)
|
|
Part I assessment
|
45 days: 26 for the reporting Member State's draft, 12 for coordinated review, 7 to finalise
|
Up to 31 more days (12 for sponsor response)
|
|
Part II assessment
|
45 days, by each Member State concerned
|
Up to 31 more days
|
|
Decision
|
5 days per Member State
|
|
1. Validation RFIs from incomplete dossiers
Every validation RFI adds up to 15 days before assessment starts. Most come from missing documents or inconsistent information between documents. A completeness check against the CTR annex before submission is the cheapest time saving in the process.
2. Part II documents for each Member State
Part II is assessed nationally. Each Member State concerned needs its own informed consent forms in the local language, recruitment arrangements, site suitability, investigator details and compensation information. In a six-country trial, this is the largest volume of documents, and the one most likely to be late.
3. The 12-day RFI response window
Twelve days is short when the answer needs input from medical, statistics, CMC and country teams. Teams that pre-assign owners for likely question areas, and track open RFIs in one place, answer within the window more reliably.
4. Uneven readiness across countries
Part I is coordinated, but the trial can only start in a Member State once that country's decision is issued. If one country's Part II package is late, that country's start date moves, even when the others are ready.
5. Substantial modifications
A substantial modification goes back through assessment of Part I, Part II or both. A protocol amendment that touches many countries restarts part of the clock, so amendment planning is part of start-up planning.
EU start-up checklist
- Check the dossier against the CTR annex before submission
- Prepare Part II documents per Member State in parallel with Part I, not after
- Confirm local-language ICFs are translated and reviewed before submission
- Pre-assign RFI owners by topic and agree a 12-day response plan
- Track validation, assessment and decision dates per Member State
- Plan site activation by country decision date, not trial-level approval
- Bundle non-urgent changes to reduce the number of substantial modifications
What this means by role
- Clinical operations directors and associate directors: plan first patient in by country, using each Member State's decision date.
- Study start-up leads and CTMs: Part II documents and RFI responses are where most controllable days are lost.
- Regulatory affairs teams: a pre-submission completeness check prevents the most common validation RFIs.
- eTMF managers: CTIS submissions and decisions are essential records; file them per country as they arrive.
- CRAs and site staff: site suitability and investigator documents for Part II are often the last items requested.
How Cloudbyz approaches this
Cloudbyz CTMS and Study Start-Up, built natively on Salesforce, are designed to track start-up by country and site: document collection, ethics and regulatory milestones, contracts and budgets, through to site initiation. Cloudbyz eTMF keeps submitted documents and decisions filed with metadata and an audit trail. Cloudbyz is also developing clinTranslate, an AI translation tool for trial documents, which is relevant to multi-language Part II packages.
The AI RegCheck Agent, currently in development, is designed to review regulatory dossiers for gaps and inconsistencies before submission. Its first focus is US submissions; EU coverage should be confirmed with the Cloudbyz team.
The Cloudbyz team can show how country-level start-up, document collection and milestones are tracked in Cloudbyz CTMS. Book a demo or visit cloudbyz.com.
