National Institute for Health and Clinical Excellence (NICE)
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NICE collaboration on streamlined licensing and patient access process for new medicines opened on January 1st

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.

Prof Gillian Leng CBE, Chief Executive of NICE said: “NICE has a central role in ensuring flexible and swift access to innovative medicines for patients in England and supporting the life sciences sector to launch their products here. Partnering with the MHRA and others to build this frictionless pathway to the timely availability of cost-effective medicines is one of the ways NICE is delivering benefits for patients, the NHS, and life sciences industry.”

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.

Lord Bethell, Minister for Innovation said: “We are absolutely determined to make sure UK patients can access the latest cutting-edge medicines as quickly as possible to help everybody live longer, healthier and happier lives.

“Now we have left the EU, we have the freedom to innovate and cut red tape to speed up the approval process for new treatments and ensure patient safety is at the heart of everything we do.

“The new pathway represents a totally new way of thinking and is a truly collaborative approach between the healthcare system, the pharmaceutical industry and patients with the common goal of getting the best products to the people who need them as safely and quickly as possible.”

Dr June Raine CBE, Chief Executive, Medicines and Healthcare products Regulatory Agency comments: "Transforming the way innovative medicines reach patients in the UK is not a ‘nice to have’. It’s a ‘must do’. An imperative. And the time to do it is now.

"We are transforming the MHRA, making the regulator an enabler of innovation. Our new Innovative Licensing and Access Pathway has established new partnerships to robustly and safely support all new medicines at any point in their development, and most important of all, involve patients in all aspects of decision-making.”

Further information about the Innovative Licensing and Access Pathway (ILAP) for medicines is available here:

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