Despite complaints from industry and the academic community about administrative and cost burdens – not to mention lack of clarity, consistency and transparency – in the implementation of the European Union’s Clinical Trials Directive (2001/20/EC), the vast bulk of trial applications are being approved under the legislation.
Addressing the second joint meeting on drug legislation of The Organisation for Professionals in Regulatory Affairs (TOPRA) and the European Medicines Agency (EMEA) in London last week, Christian Steffen from the German regulatory agency BfArM noted that, as of September 2007, more than 15,000 trial applications had been filed under Directive 2001/20/EC and 97.1% of these had been approved by the competent authorities. Of the remaining applications, 1.2% had been rejected and 1.7% withdrawn.
Areas highlighted by Steffen in which there were difficulties with the implementation of the Directive, albeit problems that could be remedied within the present legal framework, included:
– Differing definitions of investigational and non-investigational medicinal products, background treatments and non-interventional studies between member states (MSs).
– Additional national requirements for clinical trial applications and disparate member state decisions on the same dossier.
– Different requirements for labelling and for good manufacturing practice documentation when the investigational medicinal product is manufactured in a third country.
– Ethics committees and national competent authorities not working in parallel while ethics committee approval is a prerequisite for the clinical trial application (CTA).
– Different time lines from MS to MS for assessment of a CTA.
A number of these issues could be addressed through subgroups (e.g., on applications, scientific harmonisation) of the Clinical Trials Facilitation Group, the ad hoc working group of clinical trials professionals from the European medicines agencies set up to co-ordinate the implementation of Directive 2001/20/EC across the EU.
