The UK is taking steps to support the development and manufacture of innovative medicines in microgravity. Through collaborative work between the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Space Agency, the UK has published the first dedicated regulatory pathway for space-manufactured medicines and issued a joint statement from the UK Space Agency, MHRA, Regulatory…

The Innovative Licensing and Access Pathway (ILAP) and the MHRA-NICE Aligned Pathway both support earlier patient access to safe and effective medicines but they serve different purposes and are accessed at different points in development. The ILAP provides early, coordinated development and access support, while the Aligned Pathway brings together the Medicines and Healthcare products Regulatory…

As part of the shift towards a risk-proportionate regulatory framework, the MHRA’s Clinical Trials Unit ran a Route B substantial modifications pilot from 1 October 2025 to 31 March 2026 to test a new process to streamline the review of modifications to low-risk approved clinical trials.

Any modification that will be eligible under section 11B of the Medicines for Human Use (Clinical Trials)…

A new era for healthcare

Artificial intelligence (AI) is ushering in a new era, with the potential to reshape the world as we know it. In healthcare, it’s already starting to have an impact.

AI can support earlier diagnosis and reduce the administrative burden on clinicians, giving them more time to focus on patient care.

For patients, this could mean faster answers, more personalised…

The refreshed Innovative Licensing and Access Pathway (ILAP) is setting a new global benchmark for accelerating patient access to transformative medicines in the UK. More than just a regulatory pathway, the ILAP is the first end-to-end access pathway that brings together medicine developers with UK regulators and the National Health Service (NHS) though a genuinely collaborative and joined-up…

The rapid evolution of artificial intelligence (AI) is transforming healthcare, offering new opportunities to improve patient outcomes, enhance clinical decision-making, and increase system efficiency. At the same time, it presents complex regulatory challenges that existing frameworks were not specifically designed to address.

Over the past 2 years, the Medicines and Healthcare products…