Plans to speed up access to medicines within the NHS in England have been confirmed by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE).
The government’s recently published 10-year NHS plan stated that MHRA would adopt 'a more pro-innovation approach to regulation’ and work with NICE to deliver faster decisions on new treatments.
Now, the two agencies have announced a joint information sharing agreement that will allow pharmaceutical companies to register early with both regulators to allow parallel decision making over licensing and value.
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The regulators said the coordinated approach will offer medicine developers an integrated advice service and an aligned pathway to help them streamline both regulatory and Health Technology Assessment requirements, and 'provide a clearer route to help get their treatments to patients'.
They claim patients in England will receive the newest medicines three to six months earlier as a result of the agreement.
To benefit from the service, companies need to register their products on UK PharmaScan, the national horizon scanning database, at least three years before their expected marketing authorisation.
Lawrence Tallon, chief executive of the MHRA, said the agreement marks 'an important step in delivering smarter regulation'.
The initiative was welcomed by Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry.
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He said: 'Streamlining approval processes will allow both agencies to give patients earlier and equitable access to the innovative medicines needed to improve UK health outcomes.'
According to Dr Sam Roberts, chief executive of NICE, medicines are already being evaluated 'faster than ever before'.
He highlighted figures showing that the time between licence and guidance was cut by 26% in the 12 months to March 2025.
'When companies work with us to reduce timelines, NICE guidance is published on average just 48 days after licence,' Dr Roberts added.
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The announcement of the joint information sharing agreement follows plans announced by the MHRA to speed up access to innovative medical devices.
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