Eliza Slawther

There is “a lot of flexibility” in the European Medicines Agency’s reflection paper on the use of artificial intelligence during drug development, which is principles-driven rather than setting rigid recommendations, says the agency’s Florian Lasch.

Decentralized manufacturing methods for cell and gene therapies will be critical for improving patient access to treatments, but sponsors must prepare to demonstrate “comparability” with centralized manufacturing.

Regulators from the US, EU, Japan and UK discuss the merits of regulatory convergence for cell and gene therapies, but say that practical challenges often limit their ability to align on pharmaceutical regulatory processes.

Sponsors can expect to see a copy of final guidance on how to comply with the UK's new clinical trials regulation in August 2025, while the new framework is set to apply from January 2026.

EU regulators have recommended extending a pilot on the use of raw clinical trial data in medicines evaluations after an interim review of the initiative found that using such data improved regulatory decision-making.

The UK's drug regulator has approved Eli Lilly's early Alzheimer's drug Kisunla, but England's health technology assessment agency NICE said that the product “does not currently demonstrate value” for the National Health Service.

The UK government has introduced draft legislation that will regulate the manufacturing of innovative medicines such as cell and gene therapies at the point of care. The country's medicines regulator, the MHRA, says the framework is the “first of its kind in the world.”

Cell and gene therapy manufacturers based in Europe should speak to local regulators to understand how to demonstrate compliance with EU-level good manufacturing practice guidelines, as each country will apply the rules differently, an expert explains.

The European Medicines Agency should be responsible for the regulatory oversight of AI in the drug development process in the EU and provide clarity on its “risk-based” approach to governance, pharma industry federation EFPIA says.

The move towards greater regulatory collaboration is a positive step for gene therapy developers, Astellas' gene therapy strategy lead Richard Wilson says – adding, however, that pharma still needed to understand the Asian markets better.