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Update: More flexibility for EU drug trial harmonization scheme

This article was originally published in SRA

Executive Summary

Drug companies conducting clinical trials in the EU using the voluntary harmonization procedure (VHP) can now increase the number of member states in which the trial is being conducted. To do so, they must ask the scheme co-ordinator, the Heads of Medicines Agencies, to carry out a "second round" of evaluation. Companies will need to ensure, however, that the number of additional member states requested does not exceed the number of member states in the initial VHP1.




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