Obtaining clinical trial approval (CTA)
Starting with the process, the sponsor must apply for certification to conduct a Clinical Trial Authorisation (CTA) for clinical investigations. Under the EU Clinical Trial Regulation (CTR 536/2014), sponsors are required to use the Clinical Trials Information System (CTIS) to apply for authorization to conduct clinical trials within the European Union and European Economic Area.
CTIS serves as a single entry point for sponsors and regulators, streamlining the process and improving transparency across member states.
Sponsors submit a single clinical trial application dossier through CTIS, which is valid across all selected EU/EEA countries.
The dossier is divided into Part I (scientific and technical data) and Part II (country-specific and ethical data), allowing simultaneous assessment by multiple Member States.
A Reporting Member State is designated to coordinate the Part I assessment, while each concerned Member State evaluates Part II.
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