MHRA Innovation Accelerator: Why early regulatory engagement matters more than ever

The Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Accelerator, launched in July 2026, provides a single, coordinated route for developers of innovative medicines to access regulatory guidance and development support¹. It is particularly valuable for sponsors developing cell and gene therapies (CGTs), ATMPs, digital health technologies, and other novel products¹. By bringing together multiple MHRA innovation support functions under one framework, the Accelerator aims to simplify regulatory engagement, by enabling earlier access to expert advice, and helping sponsors address development challenges more efficiently. The MHRA intends the programme to support earlier regulatory engagement and help developers navigate regulatory uncertainty. In this blog, Michelle Dawson, Senior Director, Product Development Consulting, explores what this means for sponsors.

Why early regulatory engagement matters

For developers of innovative products, regulatory strategy can be as important as scientific innovation itself. Cell and gene therapies, advanced therapy medicinal products (ATMPs), digital health technologies, AI-enabled healthcare products, and other novel modalities often raise unique questions regarding classification, manufacturing, evidence generation, and clinical development requirements.

Historically, obtaining answers to these questions required engagement with multiple MHRA groups and support mechanisms, each serving different purposes and operating through separate processes. Whilst valuable, navigating this landscape could be challenging, particularly for emerging biotechnology companies with limited regulatory resources.

The Innovation Accelerator has been created to address this challenge by providing a single coordinated route into MHRA expertise and support services.

What is the MHRA Innovation Accelerator?

Launched in July 2026, the Innovation Accelerator brings together several existing MHRA innovation support functions within a single framework¹. Its objective is to help innovators navigate regulatory uncertainty, access relevant knowledge earlier in development, and support more efficient progression toward clinical studies and eventual patient access.

The Accelerator consolidates a number of existing MHRA capabilities, including:

• MHRA Innovation Office
• Regulatory Advice Service for Regenerative Medicines (RASRM)
• Regulatory Science activities
• Horizon Scanning functions
• Innovation support activities associated with the Innovative Licensing and Access Pathway (ILAP)

By coordinating access to these resources, the MHRA aims to provide developers with a clearer route to obtaining the advice and support needed to advance innovative products through development.

Who should consider the Innovation Accelerator?

The Accelerator is particularly relevant for sponsors developing¹:

• Cell and gene therapies
• Advanced therapy medicinal products (ATMPs)
• Regenerative medicines
• Digital health technologies
• AI-enabled healthcare products
• Novel manufacturing platforms
• Other innovative medicinal products and healthcare technologies

It is especially valuable for companies that have not previously engaged with the MHRA through Scientific Advice and are seeking clarity on potential development pathways.

Based on our experience at Fortrea, the greatest value can be obtained during the transition from discovery into early preclinical development, before major investments have been made in IND or CTA-enabling studies.

The benefits of early engagement

One of the principal advantages of the Innovation Accelerator is access to regulatory and scientific expertise at a stage when development plans remain flexible.

Early discussions can help sponsors address questions relating to:

• Product classification
• Regulatory pathway selection
• Clinical development strategy
• Manufacturing and CMC considerations
• Novel technologies and methodologies
• Evidence generation requirements

For advanced therapy developers, coordinated access to expertise can be particularly valuable when addressing topics such as environmental and GMO considerations, manufacturing strategy, nonclinical development planning, and first-in-human trial requirements.

By identifying potential regulatory challenges earlier, sponsors may be able to reduce development risk, avoid unnecessary studies, and design programs that are better aligned with regulatory expectations.

How does this differ from the previous approach?

Before the Innovation Accelerator, sponsors often needed to determine which MHRA function was most appropriate for their specific questions and engage separately with multiple groups.

A typical advanced therapy developer might have:

• Contacted the Innovation Office for initial pathway discussions
• Approached RASRM for regenerative medicine-specific questions
• Requested formal MHRA Scientific Advice for detailed development issues
• Applied separately to ILAP if seeking expedited support mechanisms
• Engaged independently with organisations such as the Health Research Authority (HRA), Human Tissue Authority (HTA), Human Fertilisation and Embryology Authority (HFEA), or NICE when required

The Innovation Accelerator introduces a more streamlined model by allowing sponsors to enter through a single route, with the MHRA coordinating access to the relevant expertise and services.

When should sponsors engage with the MHRA Innovation Accelerator?

For many innovative programs, the ideal time to consider the Accelerator is during late discovery or early preclinical development, before key development decisions become fixed.

Engaging prior to commencing IND or CTA-enabling studies allows sponsors to incorporate regulatory feedback into preclinical, manufacturing, and clinical development plans when changes can be implemented most efficiently.

As a practical guideline, we recommend that companies should consider initiating discussions at least six months before the planned start of an IND or CTA-enabling programme to allow sufficient time for internal planning, regulatory interactions, and incorporation of lessons learned.

Strategic implications for Sponsors

The global development landscape is becoming increasingly complex as advanced modalities continue to grow alongside traditional small molecules and biologics. As therapies become more innovative, the importance of early regulatory engagement increases.

The MHRA Innovation Accelerator represents an important evolution in the UK's innovation ecosystem by creating a more coordinated mechanism for regulatory engagement. For sponsors developing next-generation therapies and technologies, it offers an opportunity to gain earlier insight into regulatory expectations, reduce uncertainty, and establish a development strategy that supports efficient progression through key development milestones.

For biotechnology companies evaluating where and how to conduct early clinical development, initiatives such as the Innovation Accelerator may become an increasingly important factor when assessing development timelines, regulatory risk, and overall programme feasibility.

Engage Fortrea’s regulatory strategy group to review your development program and define the most effective path forward.

Frequently Asked Questions

Q. What is the MHRA Innovation Accelerator?
A. The MHRA Innovation Accelerator is a UK initiative launched to provide innovators with a coordinated route to regulatory support and guidance during product development. It brings together several existing MHRA innovation support functions to help developers of novel medicines and healthcare technologies navigate regulatory challenges and access relevant expertise earlier in development¹. 

Q. Who can benefit from the MHRA Innovation Accelerator?
A. The Innovation Accelerator may be relevant for companies developing innovative medicines and healthcare technologies, including cell and gene therapies, advanced therapy medicinal products (ATMPs), regenerative medicines, digital health technologies, AI-enabled healthcare products, and other novel modalities. It can be particularly useful for sponsors seeking early regulatory feedback as they define development and clinical strategies¹.

Q. When should companies engage with the MHRA Innovation Accelerator?
A. Many developers choose to engage during late discovery or early preclinical development when key decisions around manufacturing, nonclinical studies, and clinical development planning are still being shaped. Early engagement can help organisations better understand regulatory expectations before major development investments are made.

References

1. Introduction to the Innovation Accelerator. 
   Medicines and Healthcare products Regulatory Agency. https://www.gov.uk/government/publications/innovation-accelerator/innovation-accelerator. Last updated 29 July 2026. Last accessed 7 August 2026