The European Union comprises 28 countries that require CE Marking . Three additional countries (Norway, Iceland, Liechtenstein), although not officially part of the European Union,...
Single Medical Research Regulatory Framework Championed in the UK
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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:
- the creation of a new Health Research Agency (HRA) to oversee all medical research activities in the UK;
- the establishing of a new National Research Governance Service within the HRA to expedite approval of research studies;
- improving the overall environment within the UK for clinical trials;
- improving access to patient data for more effective research;
- and embedding a culture valuing research within the National Health System.
Access to the Academy’s full report, as well as responses to the proposal, are available here. A more well-oiled research regulatory infrastructure could make the UK a more attractive market in which to conduct clinical trials and gain approval for medical device and IVD products.