Articles: 1-10 of 45
Provisional agreement on the EU Pharma Package before 2025 comes to an end
European Union - December 16 2025 On 11 December 2025, it was announced that the Council of the European Union and European Parliament reached an agreement on the EU Pharma Package…
Navigating the interplay of MDR and AIA: New MDCG Guidance on Medical Device AI Under the EU AI Act: EU and UK perspectives
European Union, United Kingdom - October 27 2025 The EU regulatory landscape for medical devices making use of artificial intelligence (MDAI) has become significantly more complex with the…
UK Launches World-First Framework for Decentralised Medicine Manufacturing
United Kingdom - October 23 2025 The UK has become the first country in the world to introduce a dedicated legal framework for the point of care (‘PoC’) and modular manufacture of…
Fit for the Future: England’s 10 Year Health Plan and Implications for US Companies
United Kingdom, USA - September 25 2025 England’s National Health Service (NHS) is seen as one of the world’s most ambitious and comprehensive healthcare systems, but has been in desperate…
Navigating Digital Health: When Software Becomes a Medical Device - Critical Legal Considerations for Technology Suppliers in the Healthcare Sector
European Union - September 4 2025 As digital health applications become increasingly sophisticated and telemedicine (the distribution of health-related information and services…
EU Pharmaceutical Law Reform: New Framework for Combination Products
European Union - August 18 2025 As part of its pharmaceutical law reform, the EU legislator has proposed a modernised framework for combination products - products that combine…
EU Pharmaceutical Law Reform: Council advances paediatric medicine reform with more flexible investigation plan proposals
European Union - August 14 2025 On 4 June 2025, the Council published its stance on the “pharma package”, introducing notable changes that will influence how paediatric medicines…
Council adopts its position on EU pharmaceutical law reform: focus on antimicrobials and transferable data exclusivity vouchers
European Union - August 4 2025 This article is part of a series covering updates to the proposed European Union (EU) pharmaceutical legislation reform, known as the ‘pharmaceutical…
The European Commission’s draft for a Critical Medicines Act (CMA): Disruptive Changes in Public Procurement?
European Union - July 16 2025 On March 11, 2025, the European Commission introduced the Critical Medicines Act (CMA), a legislative proposal that significantly impacts public…
EU Pharmaceutical Law Reform: Key Changes on Advertising of Medicinal Products
European Union - July 8 2025 In 2023, the European Commission proposed a comprehensive update of the key EU pharmaceutical legislation (the "Pharma Package") to address critical…
About BioTalk
Featured authors
