BIOTECH ACT I: THE ROAD TO HEALTH IS PAVED WITH GREAT INNOVATIONS
April 3, 2026
"A single, open authorization application for studies combining a medicinal product and a medical device or an in vitro diagnostic medical device."
On 16 December 2025, the European Commission proposed the "European Biotech Act" (Biotech Act I), a proposal forming the first phase of a strategic initiative intended to strengthen the position of the European Union ("EU") on the international stage in the health biotechnology sector. Feedback and initial analysis from Agathe Simon and François-Maxime Philizot, partners at Mercure Avocats.
Initially announced in the "Political Guidelines of the Commission" for the 2024–2029 term, Biotech Act I responds to a political and strategic urgency highlighted in 2024 by tw...
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