The European Commission is set to assess how to streamline regulatory pathways for the biotechnology and biomanufacturing sector as part of a broader push to find ways to boost the industry. Officials see the assessment as a potential precursor to an EU Biotech Act.
“Innovative biotechnologies and products may encounter regulatory obstacles at both member state and EU levels when entering the market,” the Commission wrote communication sent to the other EU bodies on 20 March. “Developers of biotech health products have difficulties in navigating the complex EU and national-level regulatory environment and the intrinsic complexity characterizing those innovative treatments.”
The Commission cited the existing regulatory framework for developing and using biotech-based medicinal products as an example of the complexity and shortcomings of regulation today. Depending on the nature of their products, companies may need to comply with multiple complex pieces of legislation “covering medicinal products, advanced therapies, medical devices and in vitro diagnostics, substances of human origin, genetically modified organisms and clinical trials, both at the national and EU level.”…
