CTA / Europe
A Clinical Trial Application (CTA) provides comprehensive information about the investigational medicinal product(s) and planned trial, enabling regulatory authorities to assess the acceptability of conducting the study.
Clinical trials are currently regulated by Directive 2001/20/EC, superseded by the Clinical Trial Regulation 536/2014, which was published on 27 May 2014.
The content of the CTA for CAs and ECs is described in distinct EU detailed guidances, which have been more or less strictly implemented in the national laws. The structure and format of the CTA dossiers is country-specific; CTA dossiers do not follow the Common Technical Document (CTD).
The CTA in the European Union is protocol-specific and is submitted via country-specific portals or the centralized EU Clinical Trials Information System (CTIS).
The EU requires a new CTA for any new protocols amended. The CTA often includes an Investigational Medicinal Product Dossier (IMPD) summarizing CMC, nonclinical, and clinical information. Pre-submission meetings can be requested. It is typically approved or rejected with specific grounds for non-acceptance.
The CTA can be used in most countries outside the US, including the EU, UK, and Canada.
Planning for submissions to multiple countries requires careful consideration of these differences to ensure efficient drug development programs.
As a solution, we offer:
- Guide you through EU regulation
- Registration strategy for clinical trials in Europe
- Support for CTA (Clinical Trial Application) preparation and submission (as per CTD – Clinical Trials Directive or new CTR – Clinical Trials Regulation), including requirement by countries: Writing protocol, Investigational Brochure
- Attend meeting as required by agencies
- Coordinate various activities for submission
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