EFPIA and Vaccines Europe (VE) support the European Commission’s Biotech Act II and its goal of strengthening Europe’s biotechnology and biomanufacturing ecosystem. They argue that the legislation should focus on improving framework conditions for advanced and innovative manufacturing rather than creating overlapping regulatory requirements.

The organizations express concern that the revised General Pharmaceutical Legislation significantly narrows the scope of decentralised manufacturing, limiting its use to niche applications. They believe this could undermine Europe’s competitiveness, supply chain resilience, and ability to keep pace with developments in the UK and US. They therefore call for regulatory frameworks that support broader adoption of decentralised and modular manufacturing models.

EFPIA and VE also advocate removing outdated regulatory requirements, particularly duplicate batch release testing for imported medicines already tested under equivalent GMP standards. Extending waivers for such testing would reduce administrative burden, improve supply chain efficiency, and strengthen international regulatory cooperation while maintaining safety and quality.

Finally, they stress that Europe’s competitiveness depends on strong clinical research, regulatory predictability, digitalisation, data infrastructure, and IP protection rather than localisation requirements. Biotech Act II should prioritise regulatory simplification, innovation, investment predictability, and sustainable biomanufacturing to support growth across globally connected value chains.