Issued by: Medicines and Healthcare products Regulatory Agency and National Institute for Health and Care Excellence

Under a joint information sharing agreement, pharmaceutical companies will be invited to register early with the MHRA and NICE to allow parallel decision making over licencing and value.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) today (Wednesday, 6 August) described how the 10-Year Health Plan will lead to faster medicines access for patients in the NHS in England.

Under a joint information sharing agreement, pharmaceutical companies will be invited to register early with both agencies to allow parallel decision making over licencing and value. It will mean more medicines receive approval for use on the NHS in England at the same time as they are licensed for use in the UK. It’s anticipated that patients in England will receive the newest medicines 3-6 months earlier as a result.

Part of the 10-Year Health Plan and industrial strategy, the new joint service reflects the government’s commitment to smarter regulation, with a target to cut administrative costs for businesses by 25%.

The enhanced coordinated approach offers medicine developers an integrated advice service and an aligned pathway to help them streamline both regulatory and Health Technology Assessment (HTA) requirements and provides a clearer route to help get their treatments to patients.

To benefit from this service, companies should register their products on UK PharmaScan, the national horizon scanning database, at least three years before their expected marketing authorisation.

Health and Social Care Secretary, Wes Streeting, said:

“This government is slashing red tape and turbocharging economic growth of the life sciences sector so patients can get the innovative treatments they need, faster.

“To save our NHS and make it fit for the future we have to do things differently. By having two of our most important regulators join forces we’ll rapidly remove barriers, get patients access to vital medicines, and grow the economy.

“With a technological and life sciences revolution taking place, Britain should be at the forefront of it. Our 10 Year Health Plan and Life Sciences Sector Plan will help us drive the breakthroughs we need to be best in class and boost growth across the country.”

Lawrence Tallon, Chief Executive of the MHRA, said:

“We are completely focused on making sure patients can benefit from safe, effective and affordable medicines and treatments as soon as possible.

“We are working in closer partnership with NICE to build a faster and more efficient regulatory system, designed to accelerate UK market entry and deliver innovative, life-changing treatments to NHS patients faster.

“This marks an important step in delivering smarter regulation – strengthening UK’s global life sciences offer and reinforcing our position as an attractive destination for innovation and international investment.”

Dr Sam Roberts, Chief Executive of NICE, said:

“Patients in England are already receiving medicines much earlier as NICE is evaluating treatments faster than ever before. In the year to March the time between licence and guidance was cut by 26% and when companies work with us to reduce timelines NICE guidance is published on average just 48 days after licence.

“This joint working with our partners at the MHRA will allow us to accelerate medicines into the NHS even further to help transform the health of the nation, alleviate pressure on the service where possible and support a thriving life sciences sector in this country.”

Mark Samuels, Chief Executive of Medicines UK, said:

“This new joint approach between NICE and the MHRA is very welcome, particularly in supporting the earlier launch of new biosimilar medicines, which means more patients can be treated sooner.

“Streamlining market entry will further enhance the UK’s attractiveness as a first-choice country for introducing new medicines.”

Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry, said:

“We welcome this initiative, which represents one of many necessary improvements in the UK health and life sciences ecosystem. Streamlining approval processes will allow both agencies to give patients earlier and equitable access to the innovative medicines needed to improve UK health outcomes.

“We look forward to continued progress in other areas to enable the life sciences sector to fulfil its growth potential for the benefit of patients, the NHS and the economy.”

Notes to editors

About MHRA

• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

• The MHRA is an executive agency of the Department of Health and Social Care.

• For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.

About NICE

NICE’s core purpose is to help practitioners and commissioners get the best care to people, fast, while ensuring value for the taxpayer.

We do this by:

• producing useful and usable guidance for health and care practitioners

• providing rigorous, independent assessment of complex evidence for new health technologies

• developing recommendations that focus on what matters most and drive innovation into the hands of health and care practitioners

• encouraging the uptake of best practice to improve outcomes for everyone.

To find out more about what we do, visit our website: www.nice.org.uk and follow us on social media: https://linktr.ee/nicecomms

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