Clinical Trials Authorisations in the EU
Following the implementation of the Clinical Trials Directive in May 2004 all EU member states (MS) operate the one system of clinical trial authorisations (CTA). However, this does not mean that the system is harmonised in the same way as Marketing Authorisation Applications. Although nominally all MS receive the same dossier, each assesses the data according to its own procedures and gives its own approval: there is not a single CTA across the EU analogous to the single Marketing Authorisation.
While the data requirements appear to be the same across the EU, careful study of the guidelines shows that some MS need to see more supporting data than others. Often this is non-product-related information, such as contracts between the investigators and the sponsor, or proof of insurance cover, or sometimes text of advertisements designed to recruit subjects.
Another way in which countries differ in their approach to clinical trials is their interpretation of collateral guidelines or the level of detailed assessment of data, particularly CMC. Sometimes this detailed scrutiny takes the assessment beyond the 60 day limit set in the Directive, while another authority might have approved the same protocol in less than half the time.
Assessment times provide the clearest example of how agencies vary in their approach to CTAs. The Directive requires the competent authorities (CA) to complete their assessments within 60 days from validation of the application. Some CAs have undertaken to do this within shorter timelines: Belgium, Austria and UK for example. Indeed the UK authorities aim for a 14 day review time for Phase I studies.
The application of the strict 60 day time limit (more strict in some MS than others!) means that if questions are raised the agency can only allow you a few days in which to provide your responses - some may allow you 14 days while others expect a response in 24 hours.
All these variables can make setting up a multinational study, even within the borders of the EU, an uncertain and time-consuming project. Akos can help you plan the initiation of the clinical trial programme, producing a timetable for document generation, dossier submission and agency approval. If questions are raised by the assessors we can help you provide your response within the 60 day limit. We can also write the IMPD and IB and set up Scientific Advice or Protocol Assistance meetings. All the combined expertise of Akos is at your disposal.
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk