CASMI is part of the expert group working on the UK Adaptive Licensing bid. In the recent ‘Strategy for UK Life Sciences: One Year On’ report, the Prime Minister announced that CASMI will be co-ordinating the exploration of candidate products for AL:
As agreed in the Strategy for UK Life Sciences, a group of experts drawn from government, regulators, the NHS, industry, and the academic and third sector communities was set up this year by the MHRA and has been meeting regularly to discuss healthcare regulation issues. The work of the Expert Group picks up the challenge set in the Strategy to generate ‘next step’ proposals for regulatory innovation which led to the development of the adaptive licensing project. The Expert Group and its supporting working groups have met regularly to coordinate the different workstreams coming out of the project, agreed on a tripartite programme of work and are committed to meeting the Prime Minister’s request to set up a pilot by the end of the year.
A key aspect of the proposed pilot is to advance and maximise the potential of existing drug licensing processes by encouraging collaborative and pro-active use of support mechanisms, to improve public health and to stimulate innovative drug development. This comprehensive tripartite programme will draw together:
• Work at the EU level on how the existing flexibilities in EU regulation can be used to bring forward innovative products, including a discussion about the most efficient use of data-gathering methods and its implications for drug licensing and safety monitoring procedures.
• Work at the national level, conducted by the MHRA and the Expert Group, exploring options to help companies maximise the potential of existing drug licensing processes. A retrospective analysis of licensed medicines is planned to consider whether alternative pathways could have been used, with a view to informing and influencing debate nationally and at EU level.
• Work at arms-length from the MHRA and the Government. The co-ordination of some other activities required for the pilot will have to be undertaken at arms-length from government and industry by the Centre for the Advancement of Sustainable Medical Innovation. This will include the exploration of suitable candidate products.
The full report can be read here.