August 2025 marks two years since revisions to Annex 1 of the European Union’s Good Manufacturing Practice (GMP) guidelines were introduced. Niamh Bissett, director, business transformation at West Pharmaceutical Services discusses.
The House of Lords Science and Technology Committee report on engineering biology has included several recommendations put forward by The Institution of Chemical Engineers (IChemE), highlighting critical areas for advancing the field in the UK.
Beccy Bell, associate director, laboratory services, Broughton, outlines the challenges of interpreting the guidance, and measures that can be put into place to ensure pharmaceutical products are compliant with the guidance in several jurisdictions.
Arriello’s Kate Coleman reviews the findings of new transatlantic research which charts biotechs’ evolving commercialisation strategies and regulatory preparations, and the realities they are experiencing.
Rachel Reeves is right: the UK is at the forefront of life sciences, with some world-leading research and innovation. But there’s a big hole in the plan the chancellor outlined in her big growth speech yesterday.
ArisGlobal’s director of product management’s Agnes Cwienczek, reports on AI-boosted regulatory process automation and other top-level findings from a new Censuswide survey of senior life sciences regulatory professionals.
While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe.
Some of the UK’s leading academics and industry professionals welcomed Rachel Reeves’ recent announcement of £520 million to develop the UK’s medicine manufacturing capabilities, but say creating a trained workforce must be a priority.
Human Data Sciences (HDS), a data science analytics company based in the UK, unveiled new tools that will make it easier for pharmaceutical companies to navigate the incoming Joint Clinical Assessment (JCA) regulations at the ISPOR conference.
This week’s budget saw several major announcements for the UK life sciences sector. Yogan Patel, head of life sciences for MHA, the UK member firm of the global Baker Tilly network, explores what’s been announced and what it means for the industry.