MHRA publishes updated guidance document for clinicals conducted in UK
In July, the MHRA issued an updated guidance document on clinical investigations to be carried out in the UK. It’s an update on previously available guidance that takes into account the impact of 2007/47/EC, the revision to the directives which takes effect in March 2010. One of the major updates in this document is the confirmation that it will be much more difficult to obtain regulatory approval using only clinical literature and that more products will require a clinical investigation. In addition the guidance talks about how to complete an application, outlines how it will be processed and what documentation will be required. You can download the document here.