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Client Alerts 11 results

Client Alert | 14 min read | 12.22.25

European Commission Proposes Biotech Act to Boost Health Biotechnology in the EU

On December 16, 2025, the European Commission published its proposal for a regulation establishing a European Biotech Act to strengthen the EU's biotechnology and biomanufacturing sectors with a primary focus on health.
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Client Alert | 11 min read | 12.22.25

European Commission Proposes Simplifying the Rules on EU Medical and In-Vitro Diagnostic Devices

The European Commission has proposed targeted amendments to the Medical Devices Regulation 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). The amendments are intended to simplify the rules, reduce the administrative burden, and enhance the predictability and cost-efficiency of notified body certification, while maintaining high public health and patient safety standards.
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Client Alert | 7 min read | 12.15.25

The New EU “Pharma Package:” EU Reaches Landmark Deal on Pharma Package

On December 11, 2025, the Council of the European Union and the European Parliament reached provisional agreement on the long-awaited “Pharma Package,” (see the announcement here). The Pharma Package is a comprehensive and major overhaul of the EU legislative framework for pharmaceuticals, which replaces the more than 20-year-old Directive 2001/83 and Regulation 726/2004 and incorporates (and updates) the separate regulations on orphan and pediatric medicines (Regulations 141/2000 and 1901/2006 respectively).
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Press Coverage 3 results