PATIENTS could access some new medicines three to six months earlier under plans to bring regulatory licensing and NHS value assessments closer together, according to the UK medicines regulator’s strategy to 2030.
The Medicines and Healthcare products Regulatory Agency (MHRA) set out plans today to shorten the journey from research to patient care through faster assessments, earlier advice for developers and more coordinated working with healthcare partners.
The strategy combines these measures with a patient-centred, evidence-based approach, aiming to improve access while maintaining rigorous assessment of safety, quality and effectiveness.
In the eight-point approach to achieving ‘better outcomes’, the MHRA lays out plans to work more closely with the National Institute for Health and Care Excellence (NICE), allowing licensing and value assessments to take place in parallel, rather than through previous sequential pathways.
The report says this could bring some new medicines to patients as much as three to six months earlier than before.
As well as this, an improved integrated advice service will allow developers to consult the MHRA and NICE through a single process, helping them plan studies that support both regulatory approval and assessment for NHS use.
The MHRA also plans to provide service guarantees covering initial assessments of first-in-human trials within 14 days, first assessments of licensing applications within 90 days and scientific opinions within 90 days.
Additionally, companies will soon be able to book licence application slots in advance, while more flexible scientific advice along with digital systems providing real-time visibility of application progress, will aim to improve predictability.
Higher fees for specified services will be linked to performance guarantees, with rebates where standards are not met.
A brand new MHRA benefit and risk framework, to be released in 2027, will explain how the MHRA assesses evidence and reaches regulatory decisions throughout a product’s lifecycle.
Created through consultation with patients and clinicians, it will initially cover medicines before expanding to medical devices. Overall, it will help developers understand assessment requirements and support informed choices by patients and clinicians.
The new strategy also recognises that patients may weigh benefits and risks differently according to their health, circumstances and preferences.
Because of this, it promises to implement stronger patient involvement, including deliberative sessions and citizens’ assemblies, will help inform complex decisions, supported by a refreshed involvement and engagement plan in 2026.
The agency will also identify evidence gaps and publish research priorities, beginning with a programme focused on women’s health. Working with research and healthcare partners, it will support more representative clinical studies and strengthen evidence for groups that have historically remained under-represented.
By 2030, the MHRA aims to make all product information accessible to larger audiences by making it available as structured digital content, while retaining formats such as paper and braille.
Clearer information and appropriate safeguards will also support medicine reclassification where robust evidence justifies more convenient access, including over-the-counter availability.
The MHRA’s Innovative Licensing and Access Pathway will continue supporting transformative medicines and drug-device combinations through earlier alignment with health technology assessment bodies and the NHS.
For innovative medical technologies addressing unmet clinical needs, a new Early Access Service for Devices will provide time-limited, conditional approval ahead of full regulatory assessment.
Additionally, The Innovation Accelerator scheme will help developers navigate available support and offer targeted vouchers to reduce the cost of premium regulatory services for UK start-ups, all in the hopes to boost drugs and device innovation.
Rare diseases are another priority laid out by the agency. Through its Rare Disease Consortium, the MHRA plans to develop a flexible, risk-proportionate framework and tailored advice for those developing therapies for small patient populations, which often makes traditional development pathways difficult.
Regulatory sandboxes and international Innovation Corridors will support evidence generation, testing of novel approaches, and coordinated engagement between innovators and regulatory agencies.
This, along with stronger horizon scanning, will help the agency and healthcare partners prepare earlier for emerging treatments.
The MHRA’s scientific plans include a greater use of and emphasis on real-world evidence, as well as linked health data, computational modelling, digital twins and synthetic data.
New guidance to be released on biomarkers, surrogate endpoints and statistical approaches will support assessment where traditional measures may be less suitable.
The MHRA will also develop guidance on using existing knowledge about treatment platforms across different diseases and products, rather than starting from scratch for each application.
Human-relevant alternatives to animal testing and AI-assisted review of trial documentation will support further improvements in development.
This faster access to drugs and devices will be accompanied by more continuous surveillance of medicines and devices beyond approval and in everyday use, enabling earlier identification of emerging risks or issues.
Finally, international reliance and recognition arrangements will aim to reduce duplicated assessments across countries where drugs have already been approved elsewhere, while, similarly, timely decisions on generics and biosimilars will support availability and healthcare savings.
Through work with other governments and healthcare partners, the MHRA hopes to also address supply vulnerabilities before they emerge as issues for patients and clinicians.
Across these measures, among many others laid out in the strategy, the MHRA emphasises that approval must be connected with health-system readiness and adoption, so that regulatory progress translates into effective treatments that patients can receive as soon as possible.
The MHRA’s 2030 Strategy is published today.1
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