More flexibility for EU drug trial harmonization scheme
This article was originally published in SRA
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.
You may also be interested in...
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.
An ambitious action plan drawn by an EU task force, if implemented on a priority basis by the European Commission, could increase the EU’s capacity to advise on, assess and analyze big data.
Swissmedic will scale back its review procedure for certain anti-infectives if the indications for which approval is being sought are identical to those approved in the EU or the US.