European Union: Life Sciences, Biotechnology & Nanotechnology

Since July 2026, veterinary medicines manufacturers have been subject to restructured good manufacturing practice (GMP) rules under two new EU Regulations. These standalone frameworks introduce mandatory quality obligations for finished products and active substances, replacing previous guidance-based requirements with directly applicable law. Meanwhile, the European Commission's proposed Biotech Act I aims to streamline variation procedures, simplify GMO approvals, and introduce new incentives for biotechn

The Council has adopted its position on the EU Pharmaceutical Package at first reading, with legally and linguistically revised texts now available. While the main elements of the political compromise remain intact, several clarifications warrant attention as companies refine their implementation plans and the legislative process continues toward completion.

The Council has adopted its position on the EU Pharmaceutical Package at first reading, with legally and linguistically revised texts now available. While the main elements of the political compromise remain intact, several clarifications warrant attention as companies refine their implementation plans. This analysis identifies the most relevant changes in the Council's revised texts, assesses their practical significance, and outlines the next steps in the legislative process.

This Briefing summarizes the new case law regarding the challenges of claw backs for 2017 and 2018 that have already been contested within the relevant deadlines.

La Cour des comptes examine les défis auxquels fait face la CNIL dans la gestion de l'accès aux données de santé, révélant des délais pouvant dépasser deux ans. Ce rapport soulève des questions cruciales sur la capacité des autorités françaises à soutenir le développement de l'intelligence artificielle en santé dans le contexte des nouveaux règlements européens AI Act et EEDS.

The European Commission has released a detailed Staff Working Document outlining the evidential basis for the European Biotech Act, revealing how the EU plans to address its biotechnology innovation...

The European Medicines Agency offers special status to micro, small and medium-sized enterprises developing medicines, providing financial incentives, translation services, and regulatory guidance to foster innovation. Companies meeting specific employee and financial thresholds can access fee reductions, deferred payments, and expert support through the EMA's SME office.

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The text remains subject to formal endorsement by both institutions and to legal-linguistic revision before adoption, with publication in the Official Journal expected ahead of the original...