EU Biotech Act public consultation opens for input

The EU is asking for your views on the new Biotech Act. This Act will aim to speed up the development of biotech products, like new medicines and advanced treatments, while keeping patients' safety a top priority.

The new Biotech Act will help bring more medical research and clinical trials to Europe, including Ireland. This means patients here could get access to new treatments and medicines faster, while keeping strict safety standards in place. The Act will include proposals to improve and simplify the regulatory landscape, including changes to the Clinical Trials Regulation.

What does the questionnaire look at:

You can share your views on key areas such as:

• The EU regulatory environment
• Biotech clusters & manufacturing
• Data and Artificial Intelligence (AI) in biotech

How to take part in the consultation

You can contribute to this consultation by filling in the online questionnaire.

The call is open to everyone. It is relevant to clinical trial sponsors and manufacturers of biotechnology products.

The deadline for submission is 11pm Irish Time, 10 November 2025.