| With immediate effect, the Clinical Trials Facilitation Group (CTFG), established in 2004 by the EU Heads of Medicines Agency (HMA) to co-ordinate the implementation of the EU clinical trials directive 2001/20 EC across the member states, offers a Voluntary Harmonisation Procedure (VHP) for clinical trials.
In this Voluntary Harmonisation Procedure multinational clinical trials (MN-CT) will be scientifically assessed by these National competent authorities, in the territory of which the CT is planed to be performed, according to the sponsors information. The VHP is offered in a pilot phase for clinical trials meeting the following criteria:
and any of the following :
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First in Human MN-CTs and particularly with investigational medicinal products with known or anticipated risk factors as described in EMEA/CHMP/SWP/294648/2007.
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MN-CTs with "Critical" investigational medicinal products (limited community expertise e.g. IMP with novel modes of action, novel manufacturing process, novel administration and storage requirements, links to a class of medicinal product with recognised safety concerns, unresolved pre-clinical abnormal findings, for instance monoclonal interfering with immune regulation, advanced therapies) or "Critical" MN-CTs (e.g. for limited trial populations e.g. orphan diseases, less common types of cancer, paediatrics diseases with small numbers, adult diseases with small numbers or unmet medical needs), based on NCAs judgement, endorsed by the CTFG
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MN-CTs with very large population and where the sponsor indicates a need for harmonisation (e.g. large phase III CTs and several 5-10 MS concerned)
The VHP consists of a pre-submission of a common dossier to the CTFG and a coordinated assessment by the National competent authorities concerned. After the VHP, a national Clinical Trial Application has to be filled by the sponsor according to the national laws for the approval of clinical trials. In the case of the positive VHP statement by the Member State(s) a national approval should not take longer than 10 days, after the submission of a valid application. More information on the VHP can be found in the Guidance document for a Voluntary Harmonisation Procedure (PDF, 185 kB) (VHP) for the assessment of multinational Clinical Trial Applications Version Sponsor 1.1 or on the CTFG website http://www.hma.eu/77.html
Further information on the VHP can be requested under VHP-CTFG@VHP-CTFG.eu |
