In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
8/25/2025
/ Artificial Intelligence ,
Clinical Trials ,
Cybersecurity ,
Digital Health ,
Environmental Social & Governance (ESG) ,
Genetic Materials ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Trump Administration
Following approval by EU Member States in the Trade Barriers Committee, on 19 June 2025, the European Commission adopted the first measure (Implementing regulation - EU - 2025/1197 - EN - EUR-Lex) under the International...more
The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more
On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more
The European Commission has revised the Urban Wastewater Treatment Directive (“UWWTD”), which is instrumental in mitigating urban wastewater pollution across EU. This revision, prompted by emerging environmental challenges,...more
Jacqueline Mailly and Anastasia Vernikou of Hogan Lovells and Grégoire Paquet outline the details of the EU regulation introducing a ban on Bisphenol A (BPA) in food contact materials and its implications for industry. On 20...more
The Q2/24 Life Science and Health Care Law Update covers key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) in life sciences regulatory, corporate, compliance, competition, and privacy....more
The European Union has introduced comprehensive regulations for artificial intelligence (AI) systems, encapsulated in the EU AI Act (AI Act). The objective of the AI Act is to ensure that AI systems in the EU are safe,...more
The European Commission recently put forward a draft proposal for a Regulation introducing a ban on the use of Bisphenol A (BPA) in food contact materials. As part of this legislative process, the European Commission has...more