The Clinical Trials Regulation (EU) No 536/2014 has reshaped how trials are authorised across Europe. Since the three-year transition period closed on 31 January 2025, every clinical trial with an active site in the EU or EEA must run under the Regulation and be managed through the Clinical Trials Information System (CTIS). For sponsors, this is no longer a project to plan for — it is the operating environment, and it rewards those who understand its rhythm.
One application, one coordinated assessment
The Regulation replaced a fragmented, country-by-country model with a single submission through CTIS. A sponsor running a multinational trial files one dossier and proposes a Reporting Member State, which leads a harmonised scientific evaluation on behalf of all the Member States Concerned. The dossier is assessed in two parts: Part I covers the science shared across countries — benefit-risk balance, investigational medicinal product quality and trial design — while Part II covers national and ethical matters such as informed consent, site suitability and data protection.
The result is a coordinated decision rather than a series of independent national verdicts. It removes duplication, but it also means a single reasoned objection can affect the whole application, raising the stakes on the quality of the initial submission.
Timelines demand discipline
CTR procedures run to defined statutory clocks. In broad terms, a submission is validated first, then the two assessment parts proceed within set windows before a single decision is issued. Requests for information pause the clock, and the sponsor is given a fixed period to respond. Miss that window and the application can lapse.
The practical consequence is that timelines are unforgiving of slow or incomplete responses. Sponsors who treat a request for information as a routine query, rather than a deadline-bound obligation, risk losing an authorisation they had almost secured.
Where sponsors run into trouble
Common difficulties tend to cluster around a few recurring themes:
- Underestimating CTIS itself — role assignment, user administration and document structuring inside the portal require deliberate setup, not last-minute improvisation.
- Weak or inconsistent responses to requests for information, especially when several Member States raise points at once.
- Transparency and redaction: CTIS is a public register, so sponsors must plan what becomes visible and when, in line with the Regulation’s disclosure rules.
- Substantial modifications after authorisation, which follow their own procedural path and are easy to mishandle under time pressure.
Greece within the CTIS framework
Greece participates in the CTR system like every other Member State, with the national competent authority and the ethics infrastructure feeding into the shared assessment. For companies choosing where to place a Reporting Member State role, or building a trial footprint that includes Greek sites, local procedural knowledge remains valuable even within a harmonised European process. Understanding how national requirements interact with the coordinated timeline is often what separates a smooth authorisation from a delayed one.
How PQRA helps
PQRA supports sponsors and healthcare innovators across the clinical trial lifecycle within the CTR framework. We help structure and quality-check CTIS submissions, advise on Reporting Member State strategy, prepare robust responses to requests for information, manage substantial modifications and transparency obligations, and coordinate the regulatory and ethical requirements that apply to trials involving Greek sites. Our aim is simple: to keep your application moving through the statutory clock without avoidable setbacks.
Planning a clinical trial in Greece or the wider EU, or transitioning ongoing activity under the Clinical Trials Regulation? Contact PQRA to discuss how we can support your submission strategy.
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