Medicines and Healthcare products Regulatory Agency

Following the successful development and worldwide deployment of mRNA-based vaccines during the Covid-19 pandemic, new mRNA therapies currently under development aim to tackle non-viral diseases, such as cancer. However, whereas the Covid-19 vaccine targeted a single virus with the potential to infect millions of people, these new therapies are intended to target the many unique tumour mutations of individual patients.

The personalisation of mRNA therapies is potentially revolutionary from a treatment perspective, but highly complex from a regulatory perspective as each bespoke therapy will have a slightly different risk/benefit profile. On 1 October 2025, the government published its draft guidance for a streamlined pathway to approval for individualised mRNA cancer immmunotherapies. The final guidance on the development and regulation of these treatments is expected later in 2026 and will be updated as the MHRA acquires experience of different technologies.

The latest step in the MHRA’s transformation of its medical device regulatory framework is the entry into force (in June 2025) of new post-market surveillance regulations, requiring manufacturers to actively track the safety and performance of the products they place on the market. New pre-market requirements are expected to come into effect in 2026, including the introduction of new routes to market in reliance on the approvals of certain international regulators, similar to the international recognition procedure that exists for pharmaceuticals.

In 2024 the MHRA outlined its strategic approach to regulating AI. It has seen the MHRA rolling out a variety of AI related guidance, particularly for AI as a medical device (AIaMD) and software as a medical device (SaMD), as well as piloting a regulatory sandbox for AIaMD. A new National Commission into the Regulation of AI in Healthcare was launched on 26 September 2025. This commission will review current regulations and advise the MHRA on the development of a new regulatory framework for AI to be published in 2026. It launched a call for evidence which closes on 2 February 2026. AI in healthcare is also one of the focus areas of the Regulatory Innovation Office, which is working with regulators to update regulation and drive innovation, and the MHRA is developing its own use of AI to support productivity and decision-making.

The MHRA aims to use data to streamline and harmonise its regulatory processes and procedures. It also wants to diversify the data it uses – taking on board more ‘real world data’ – and embrace new analytical approaches. In some cases this could lead to significant changes e.g. in supporting innovative evidence generation strategies for product developers.

The regulatory regime for clinical trials will change significantly in April 2026, following a 12 month implementation period. To some extent this is a belated response to Brexit: the existing regime is based on the old EU Clinical Trials Directive, which was superseded by the European Clinical Trials Regulation shortly after the UK left the EU. To compete with this new EU framework, which reflects a number of recent medical and scientific advances, the UK system is getting an upgrade.

As well as ensuring that the UK remains aligned with international standards, the new regime is intended to be more risk-proportionate, to simplify applications for authorisation of clinical trials, and to reduce the time from application to first participant. However, sponsors will have to record their trials in a public registry and publish a summary of the results – a requirement that the government hopes will support wider scientific development, reduce duplication of clinical trials (and accompanying risk to trial participants), and bolster public trust in science.