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.
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.”
Mr Streeting continued: “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.”
Lawrence continued: “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.”