MHRA and NICE to join forces to speed up medicines approval
A new approach to approving and adopting medicines will be introduced in England, the government’s recently published 10-year NHS plan has suggested – with the aim of getting innovative treatments to patients more quickly.
According to the 168-page document, the Medicines and Healthcare products Regulatory Agency (MHRA) will adopt 'a more pro-innovation approach to regulation, while maintaining safety’.
The intention is to ‘ensure that the UK is one of the best places in the world to develop and launch new products'.
By April 2026, the MHRA and the National Institute for Health and Care Excellence (NICE) will launch a joint process – backed by information sharing and joint scientific advice – to speed up decisions and reduce administrative burdens for both the NHS and industry.
The aim of the approach is to ensure patients in England can access new medicines faster than before.
Chief executive of the MHRA, Lawrence Tallon, said: ‘We are completely focused on making sure patients can benefit from safe, effective, and affordable medicines and treatments as soon as possible.
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‘We are working in closer partnership with NICE to build a faster and more efficient regulatory system.
‘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.’
Royal Pharmaceutical Society (RPS) England Board chair Tase Oputu said: ‘The plan for MHRA and NICE to create a joint task force to approve medicines is welcome.’
And she said the RPS looked forward to the government outlining in its upcoming ‘Life Sciences Strategy’ about ‘how it will resource and enable pharmacists to deliver new treatments and support the best use of innovative medicines’.
The announcement of the fast-track initiative comes amid ongoing medicine supply problems affecting pharmacies.
The All-Party Parliamentary Group (APPG) on Pharmacy recently warned that medicine shortages have become ‘a permanent and escalating’ threat to patient care, placing an unsustainable burden on pharmacy teams and disrupting the safe delivery of treatment across England.
In addition, a recent Healthwatch England survey uncovered persistent problems experienced by pharmacy patients in accessing medication due to supply-side issues, while Community Pharmacy England (CPE) research found that one in four pharmacy teams are now spending more than two hours each day sourcing alternatives for their patients.
Single national formulary for medicines to be introduced
Along with the regulatory reforms, the plan also sets out a move to a single national formulary (SNF) for medicines within the next two years.
This change is designed to streamline procurement, accelerate the adoption of cost-effective innovations and provide greater consistency across the country.
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A new formulary oversight board – supported by NICE – will sequence products based on clinical and cost effectiveness, and local prescribers, including pharmacists, will be encouraged to use those products ranked highly in the formulary, while retaining clinical autonomy if they prescribe in line with NICE guidance.
Ms Tase from the RPS commented: ‘The establishment of a single formulary can improve cost control and reduce the postcode lottery of access to medicines.
‘A one-size-fits-all approach also reduces flexibility and it’s essential that clinicians retain autonomy to exercise their own judgement to benefit individual patients.’
Meanwhile, Community Pharmacy England (CPE) said the proposals outlined in the 10-year plan align broadly with its ambitions – but stressed that more detail and appropriate funding are needed for community pharmacy.
‘The proposals are broadly aligned to Community Pharmacy England’s aspirations, but we do not yet have full details on how the community pharmacy services will operate,’ it said in a statement on its website.
‘We are keen to begin negotiations with government for the 2026/27 Community Pharmacy Contractual Framework as early as possible to ensure that these proposals will be implemented in a way that works best for our sector, underpinned by appropriate funding and seeking to avoid adding any unnecessary workload.’
Other commitments for pharmacy within the NHS 10-year plan include a pledge to ‘transition’ community pharmacy from a dispensing-focused service to offering more clinical services.
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As part of this, the government committed to increasing the role of community pharmacy in the management of long-term conditions, including treatment of obesity, high blood pressure and high cholesterol.
In addition, the plan outlined that community pharmacies will be able to provide the HPV vaccine from 2026 to those who missed out at school and that a revamped NHS App will help patients manage and remember their prescriptions.
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