{"id":335,"date":"2026-08-06T12:08:33","date_gmt":"2026-08-06T10:08:33","guid":{"rendered":"https:\/\/www.pqra.gr\/the-clinical-trials-regulation-and-ctis-one-portal-one-assessment\/"},"modified":"2026-08-27T11:37:56","modified_gmt":"2026-08-27T09:37:56","slug":"the-clinical-trials-regulation-and-ctis-one-portal-one-assessment","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/the-clinical-trials-regulation-and-ctis-one-portal-one-assessment\/","title":{"rendered":"The Clinical Trials Regulation and CTIS: One Portal, One Assessment"},"content":{"rendered":"

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 \u2014 it is the operating environment, and it rewards those who understand its rhythm.<\/strong><\/p>\n\n

One application, one coordinated assessment<\/h2>\n

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 \u2014 benefit-risk balance, investigational medicinal product quality and trial design \u2014 while Part II covers national and ethical matters such as informed consent, site suitability and data protection.<\/p>\n

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.<\/p>\n\n

Timelines demand discipline<\/h2>\n

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.<\/p>\n

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.<\/p>\n\n

Where sponsors run into trouble<\/h2>\n

Common difficulties tend to cluster around a few recurring themes:<\/p>\n