EU: Analysis Supporting the Proposed Biotech Act
The European Commission has published the analysis underpinning the proposed Biotech Act. The initiative aims to strengthen Europe’s biotechnology and biomanufacturing sectors and to accelerate the development, production and market uptake of biotechnology-based innovations.
Proposed measures include the simplification of regulatory procedures, faster authorisation pathways, improved access to research and health data, and support for investment and manufacturing capacity within Europe.
According to the Commission, these measures could reduce administrative burden and enhance Europe’s competitiveness while maintaining high standards of safety and public health protection.
Problem tree for biotech companies (Source: EU Commission staff working document | European Biotech Act):

Source:
EU Commission staff working document | European Biotech Act
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.