How long does it usually take to obtain approval for a clinical trial application in CTIS?
The time required to obtain approval to start a clinical trial in the CTIS (Clinical Trials Information System) is one of the key elements in project timeline planning. Since the entry into force of EU Regulation 536/2014, the process has been harmonized at the European level and now follows strictly defined timelines, centrally coordinated with the involvement of the European Medicines Agency (EMA), as well as the relevant national competent authorities and ethics committees.
Under the standard procedure, the assessment in CTIS is divided into two parts. Part I (scientific and general aspects) and Part II (ethical and local aspects) are evaluated in parallel. In principle, the overall assessment timeline is approximately 60 days from the formal submission of a complete application. In practice, however, the actual time to approval depends on several key factors.
An important stage is the so-called validation phase, during which the completeness of the documentation is verified. If the application contains formal deficiencies, inconsistencies, or ambiguities, the process may be paused and the sponsor will be requested to provide clarifications or additional documents. Each round of questions and responses extends the total timeline, often by several additional weeks. In extreme cases, particularly with poorly prepared submissions, approval may take significantly longer than the planned 60 days.
It should also be taken into account that for more complex trials – for example those involving an innovative Investigational Medicinal Product (IMP), a pediatric population, or advanced diagnostic procedures – authorities may use the full assessment period available to them. Conversely, well-prepared, consistent, and “CTIS-friendly” applications often proceed without significant delays, and a decision is issued within the expected timeframe.
From a project management perspective, this means one thing: the real timeline to First Patient In (FPI) does not begin in CTIS, but at the application preparation stage. The quality of documentation, protocol consistency, clarity of responses to potential questions, and the team’s experience with CTIS directly influence the speed of trial start-up. In practice, this translates into a shorter time to study activation, reduced operational delay risk, and greater overall project predictability – which today represents one of the key values for sponsors and CROs.
If you want to be sure you are entrusting your study to the right CRO, contact us. We will share our extensive regulatory experience and advise you on how to plan your activities to avoid unnecessary delays in the assessment process.
