Policy paper

Medicines and Healthcare products Regulatory Agency (MHRA) economic growth goals

Published 8 July 2026

This was published under the 2024 to 2026 Starmer Labour government

Introduction

In March 2025, the government set out in the Regulation Action Plan its vision for overhauling the regulatory landscape so that it:

• protects consumers
• supports competition
• encourages growth

At the Regional Investment Summit in October 2025, the Chancellor gave an update on delivery of the Regulation Action Plan, setting out the progress made and where the government would go further and faster. As part of this, the government announced that it would ensure the ‘key regulators’ (the 16 regulators named in the plan) had clear direction on how they can support its overriding mission to deliver economic growth. This commitment sat alongside the announcement that the existing Growth Duty would be strengthened.

Government departments have since been developing outcome-focused growth goals, where no equivalent framework already exists. These goals provide regulators with a structured set of priorities that clarify how their actions should support economic growth. They are designed to be measurable, with specific results to enable progress tracking, and accompanied by an ‘impact narrative’, which explains how regulators’ actions are expected to encourage economic growth.

This document sets out the growth goals that the Department of Health and Social Care has agreed with the Medicines and Healthcare products Regulatory Agency (MHRA).

Goal 1: assure pace, reliability and clarity in regulatory decision-making

Outcome goal

This goal will improve the speed and predictability of approvals for new products, ensuring that:

• 95% of medicines licensing decisions through the national route are determined within 210 days
• the assessment timelines for clinical trial initial applications are:
  • up to 30 calendar days for non-notifiable trials
  • 35 calendar days for modification applications without requests for further information

MHRA will do this by increasing regulatory capacity, modernising processes and improving their engagement with industry.

Key results

MHRA will achieve the following results:

• by September 2026, MHRA will launch the new MHRA 2030 strategy, setting out how it will continue to meet and exceed the high performance standards set in its key performance indicators (KPIs) and regularly publish a new, more detailed performance dashboard
• through its aligned pathway with the National Institute for Health and Care Excellence (NICE), launched in early 2026, MHRA will ensure that the average time between MHRA approval and NICE guidance for medicines is reduced by 3 to 6 months, enabling same-time regulatory and health technology appraisal decisions
• by April 2027, MHRA will have implemented a major package of regulatory reforms for medical technologies that will include indefinite recognition of CE marking for medical devices (subject to consultation), the publication of new pre-market regulations for medical technologies and increase international reliance and recognition. Working with approved bodies, MHRA will explore how the domestic route can be a fast, safe and trusted route to market for innovative products
• by the end of 2026, a stepwise approach will be adopted for the first review of phase 1 clinical trial applications, aiming to complete the assessment within 14 days
• by September 2026, MHRA will have completed the alpha phase of the first 3 tools of the artificial intelligence (AI) for Regulatory Insights, Safety and Efficiency (ARISE) programme, to streamline regulatory processes using AI
• by May 2027, MHRA will complete the next phase of the Improving Patient Information project, working towards reforms that may include replacing paper information about products it regulates with structured digital content
• MHRA will use its year chairing the international Access Consortium of regulator organisations in 2026 to focus on supporting greater alignment of regulatory processes

Impact narrative

Faster, risk-proportionate and predictable regulatory routes will optimise access and uptake of innovative medicines and medical devices, positioning the UK as an attractive market for launching products. MHRA will:

• provide a consistently reliable and robust service for innovators bringing safe and effective products to market
• make the UK a great place to conduct clinical trials
• increase UK patients’ access to ground-breaking healthcare products

Goal 2: encourage regulatory innovation to streamline patient access

Outcome goal

This goal will expand and strengthen MHRA’s pathways for innovative products so that more products built on novel technologies can move from early development through to UK regulatory approval. This will ensure that UK patients are among the first in the world to benefit from rapid access to safe and effective new products.

Key results

MHRA will achieve the following results:

• MHRA will make the use of sandboxes for essential technologies a core part of its regulatory process. A sandbox is a regulator-monitored controlled environment for developers to generate robust evidence for their innovation
• MHRA will continue its major programme of clinical trials reform, with new regulations coming into force from April 2026 to streamline application processes. By April 2027, MHRA will have developed and started the implementation of the clinical trial lifecycle package to reduce the regulatory burden across all phases of clinical trial submissions
• by April 2027, MHRA will publish a draft framework, run a consultation and plan for the implementation of the new rare diseases regulatory pathway to provide routes for very small patient populations to access life-changing new therapies
• by September 2026, MHRA will launch a new early access service for medical technologies
• by April 2027, MHRA will run 100% of requested innovation surgeries supporting small and medium-sized enterprises and academics at an early stage of development, to help optimise their route through the regulatory system
• by April 2027, MHRA will run at least 4 regional ‘innovation accelerator’ events per year
• by April 2027, MHRA will complete at least 3 enabling assessments of emerging technologies - these will include deep dives, mapping, gap analysis and recommended actions for MHRA

Impact narrative

Through continued regulatory innovation, MHRA will help position the UK as an attractive jurisdiction to develop and launch new products. This will:

• attract research and development (R&D) investment
• support the growth of the UK life sciences sector
• provide industry with certainty when planning investment

This will contribute to economic growth and improved household incomes through increased economic activity and improved health outcomes.

Goal 3: reform the regulatory framework to position the UK as a world leader in healthcare AI regulation

Outcome goal

MHRA will develop and launch a new regulatory framework that makes the UK the best environment to develop and launch AI for healthcare, in addition to the medical technology (‘medtech’) reforms committed to in goal 1. Once implemented, MHRA will monitor its success through the number of AI medical devices being brought through domestic routes or reaching the UK market through international reliance routes.

Key results

We will achieve the following results:

• in spring 2026, MHRA will consider and issue any necessary clarifying guidance on the regulation of ambient voice technology and other priority AI categories for the NHS
• in summer 2026, the National Commission into the Regulation of AI in Healthcare will issue its report on recommended changes to the regulatory framework for AI in healthcare
• by September 2026, MHRA will respond to the commission’s recommendations and begin operationalising the updated regulatory framework, with full implementation in 2027 subject to any required legislation
• by April 2027, MHRA will refresh the AI Airlock strategy for its next phase including support for new product categories like agentic AI. Agentic AI refers to AI systems composed of agents that can behave and interact autonomously to achieve their objectives
• by April 2027, subject to the implementation of the new pre-market regulation, MHRA will begin tracking the number of AI and software-based medical devices entering the UK market through UK Conformity Assessed (UKCA) routes as a measure of the UK’s attractiveness for healthcare AI innovation
• MHRA will work with international regulators to implement recognition and reliance agreements for healthcare AI, allowing UK medtech companies to sell directly into global markets

Impact narrative

This goal will directly support the ambition of the 10 Year Health Plan to make the NHS the most AI-enabled health system in the world, increasing productivity and quality of care in the NHS. It will also support delivery of the Life Sciences Sector Plan by strengthening the UK’s regulatory environment for healthcare AI and providing greater certainty for innovators and investors.

By ensuring fast, safe and trusted adoption of AI, MHRA will also encourage investment in the UK’s healthcare AI sector. By bringing clarity to the framework for AI as a medical device, MHRA will not only support the device industry’s growth, but also that of related software, such as administrative and direct to consumer products.