Calling SMEs in biotech - have your say on the regulatory framework for biotechnology and biomanufacturing in the EU

The European Commission has launched a survey covering the application of biotechnology and biomanufacturing across multiple sectors, including medical, pharmaceutical, agri-food, industrial, environmental, and marine industries. However, bioenergy and any (future) EU legislation currently under negotiation are excluded, focusing solely on existing legislation within the previously mentioned sectors.

The survey forms part of the study “Analysis of the regulatory framework for biotechnology and biomanufacturing in the EU”. It is performed on behalf of the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, the Directorate-General for Research and Innovation, and the Directorate-General for Health and Food Safety.

The main objectives of the study are:

• To gather evidence on possible policy options provided by the European Commission, enabling an assessment and comparison of these options.
• To collect data and information on challenges relating to EU and national legislation applicable to biotechnology and biomanufacturing products and processes, their implementation and enforcement, and any resulting impacts on the sector. This includes identifying areas where EU legislation could potentially be further streamlined or simplified or where implementation could be improved.

⌛ Survey Deadline: 14 April 2025

📝 Submit your responses here.