As readers will be aware, at the end of 2025, the EU institutions agreed the text of the EU Pharma Package: the wholesale change to the pharmaceutical regime in the EU that has been debated for many years. The changes introduce wide ranging amendments that impact rewards and exclusivities, supply chain set up, and procedures for generics and biosimilars. With the text of the new legislation due to be published shortly, questions are being asked about what this means for the legislative framework in the UK. The EU Pharma Package means divergence between the UK and EU is inevitable, and this is likely to have significant implications for the UK market.
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The US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program was established to facilitate earlier patient access to novel medical devices addressing serious health conditions, by offering prioritized review and enhanced communication with regulators. Despite its promise, only a small percentage of devices granted Breakthrough designation have achieved marketing authorization, reflecting persistent regulatory and evidentiary hurdles.
At the end of 2025, as part of a bundle of measures to make the EU health sector more innovative, competitive and resilient, the European Commission proposed the EU Biotech Act (the Act) aimed at repositioning the EU as a global biotechnology hub. It includes a wide range of proposals, such as access to funding, streamlined regulatory processes, and increased incentives for innovative products. The proposal signals that the EU institutions are attempting to make the EU a more pro-innovation environment, and many of the proposals will likely be welcomed by industry.
In a pre-Christmas gift, the European Commission has adopted a proposal to simplify Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR): Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices. The key elements of the revisions are summarized in a factsheet and in a questions and answers document.