NICE collaboration on streamlined licensing and patient access process for new medicines
Companies can now submit medicines for the new Innovative Licensing and Access Pathway (ILAP) following close collaboration between the NICE, drug regulators, the NHS and equivalent organisations in Scotland.
The new route for the approval of medicines aims to smooth the journey from clinical trials through to NHS patients through closer collaboration and planning between the agencies involved in each step. It will mean NHS patients will have access to innovative new medicines sooner.
The scheme will co-ordinate work by the Medicines and Healthcare products Regulatory Agency, NICE, the Scottish Medicines Consortium (SMC) and NHS England and NHS Improvement (NHSE&I) to support and advise companies launching their medicines in the UK.
NICE will be working with the MHRA to provide advice for companies on clinical trial design to ensure optimal data is generated for both regulatory approval and health technology appraisal.
The NICE Scientific Advice and Office for Market Access services will also contribute to supporting products in the ILAP.
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