biotechnology

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The current EU regulatory landscape for biotechnology is widely viewed as insufficient to be able to exploit the full potential of such technologies. Regulatory hurdles exist at EU and Member State level, and this is thought to have driven investment into other regions.

To help tackle this problem, the introduction of a new EU Biotech Act (the Act) has been proposed by the Commission to encourage innovation in areas such as health technology assessment and clinical trials. A simpler regulatory landscape, with no reduction to safety standards, will be a central aim of the Act.

However, it was announced on 20 March 2025 that the Act has been delayed until the third quarter of 2026 (initially due in the last quarter of 2025). As such, it remains to be seen what shape the Act will take, including whether any changes will be limited to setting out general guidelines, or whether it will take the form of a binding legal instrument, imposing specific measures to which Member States and EU institutions must adhere. Various studies and papers have been developed following the announcement of the proposed Act, and it is hoped that as these are finalised, they will provide further insight into what we can expect.Continue Reading EU Biotech Act– what we know so far

On 8 October 2024, the UK government launched the new Regulatory Innovation Office (RIO), which aims to “reduce the burden of red tape” faced by businesses when bringing innovations to market, including artificial intelligence (AI) healthcare technologies and engineering biology products such as vaccines and cultivated meat.

The RIO, established within the Department of Science, Innovation and Technology, will seek to reshape regulatory landscapes by working with existing regulators to accelerate approvals, bring regulations up to date and facilitate inter-regulator collaboration. The creation of the RIO is a key manifesto commitment, as part of the government’s wider mission to kickstart economic growth, aiming to provide regulatory certainty and reduce unnecessary delays.Continue Reading UK government launches new Regulatory Innovation Office to reduce red tape

On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission Communication.

The Communication, while directed towards the broader biotech sector, refers to the aim to have a resilient EU biotech ecosystem to safeguard the supply of innovative and generic medicines. It recognizes the significance of vaccine and mRNA technology research for cancer, cardiovascular infectious, and rare diseases, as well as the role of AI in personalized healthcare and diagnostics, including generative AI for medicines discovery and complex genetic diseases.

At the same time, it acknowledges the challenges found in the biotech sector in the EU due to complex regulatory obstacles both nationally and at EU level; or the uncertainty over the return of their investments. Continue Reading Commission Communication on biotechnology and biomanufacturing