Posts Tagged ‘clinical investigation’
Updated clinical trials guidance document issued by MHRA
The MHRA has recently issued updated guidance 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 the reader through making an application, outlines how it will be processed and what documentation will be required.Download here mhra-guidance-re-clinical-investigations-july-2009
For guidance as to whether your product will require a clinical investigation please contact Danielle.avadis@mediqol.com
