Aug 12, 2009
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.
The National Institute for Health and Clinical Excellence (NICE), an organization providing health care-related guidances and standards in the UK, has
The UK’s Academy of Medical Sciences has issued a new report recommending the consolidation of medical research regulations and governance under a single entity. The Academy’s report, “A new Pathway for the Regulation and Governance of Health Research,” includes five key components:
A UK Department of Health review of how British regulators managed PiP defective breast implants has identified several regulatory improvements the Medicines and Healthcare Products Regulatory Agency (MHRA) should adopt to handle similar events in the future.