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Earlier access to new medicines in the UK

The Ministerial Industry Strategy Group (MISG), an initiative that brings together relevant UK government ministers and pharmaceutical industry chief executives, asked the Medicines and Healthcare products Regulatory Agency (MHRA) and the Association of the British Pharmaceutical Industry (ABPI) to explore the feasibility and desirability of introducing a scheme in the UK to make certain new and promising medicines available to patients before they are formally licensed.

A working group co-chaired by the MHRA and ABPI – which also sought views from the public and healthcare professionals - developed a framework for an earlier access scheme to operate within the existing regulatory regime and this was reviewed and approved by MISG in early December 2009.

The report describing the key elements of the scheme, the reports of the work undertaken to gauge the views of the public and healthcare professionals and the minutes of the working group that developed it have now been published on the MHRA’s website.

The MHRA will undertake a 12-week public consultation on the scheme and how it will operate in the New Year, with a view to finalising the scheme for introduction in the UK later in 2010.

Page last modified: 22 December 2009