EFPIA urges EU lawmakers to further cut clinical trial approval timelines under Biotech Act

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked EU legislators to go beyond the modest reductions in clinical trial approval times that are currently being considered in the Biotech Act.

EFPIA argues that faster approvals are essential for bringing innovative therapies to patients more quickly and for maintaining Europe’s competitiveness in drug development.

The request comes as the EU debates the Biotech Act’s broader reforms, while the FDA in the United States has separately released its FY 2027 user fee rates for various drug and device programs.

If adopted, the proposed acceleration could shorten the start‑up phase of trials, potentially benefiting both sponsors and patients across the continent.