Today, 6 March 2026, the Council of the European Union (“Council”) published the provisional agreement on the reform of the EU pharmaceutical legislation and the new Directive [link] and Regulation [link]. Formal adoption by the European Parliament and the Council is expected in the coming months. Continue Reading Provisional text of the political agreement on the reform to the EU Regulatory Framework for Medicinal Products is published
EU Regulatory Framework
EU Digital Omnibus: What the Proposed Reforms Mean for Pharma and MedTech
On 19 November 2025, the European Commission published two legislative proposals – the Digital Omnibus on AI Regulation Proposal and the broader Digital Omnibus Regulation Proposal (“Proposals”) – as part of a wider initiative to simplify and streamline the EU’s digital regulatory framework. Together, the Proposals introduce targeted but significant amendments across a broad range of instruments, including the EU AI Act (Regulation (EU) 2024/1689), the GDPR (Regulation (EU) 2016/679), the ePrivacy Directive (2002/58/EC), the NIS2 Directive ((EU) 2022/2555), and the EU Data Act (Regulation (EU) 2023/2854).Continue Reading EU Digital Omnibus: What the Proposed Reforms Mean for Pharma and MedTech
The EU Medical Device Shake‑Up: What International Companies Should Prepare For
Global manufacturers placing medical devices or IVDs on the EU market are facing a pivotal moment. Our latest advisory sets out details on the most significant reforms to the EU framework since the MDR and IVDR took effect, with particular emphasis on what these mean for international companies. For companies headquartered outside the EU, who already face additional hurdles such as appointing an EU Authorised Representative, navigating EU‑specific labelling and language rules, and registering in EUDAMED, the Commission’s proposed changes represent both a long‑awaited easing of systemic pressures and a clear signal to reassess EU market‑entry strategies.Continue Reading The EU Medical Device Shake‑Up: What International Companies Should Prepare For
Virtual and Digital Health Digest – December 2025
Posted in AI, Data protection, Digital Health, EU Legislation, EU Regulatory Framework, IVDR, MDR, MHRA, Product Liability
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2025 and early January 2026 from the the United Kingdom, and European Union.Continue Reading Virtual and Digital Health Digest – December 2025
European institutions agree on the reform to the EU Regulatory Framework for Medicinal Products
On 11 December, after overnight interinstitutional negotiations between the European Parliament and the Council of the European Union (“Council”) and the European Commission, the institutions reached a provisional political agreement on the reform of the European Union (“EU”) pharmaceutical legislation.
This agreement concludes months of trilogue discussions and follows a much longer legislative process that began with the European Commission’s proposal adopted in April 2023, the European Parliament’s position adopted on 10 April 2024, and the Council’s position adopted on 4 June 2025 (see our detailed advisory on the Commission’s proposal and our BioSlice blog posts on the Parliament’s and Council’s positions here and here).
The provisional agreement must now be formally adopted by both the Parliament and the Council.Continue Reading European institutions agree on the reform to the EU Regulatory Framework for Medicinal Products
Updates to the EU Pharmacovigilance Rules: Key Takeaways for Marketing Authorisation Holders
On 22 July 2025, the European Commission adopted Implementing Regulation (EU) 2025/1466 (“Regulation”), updating the EU pharmacovigilance (or “PV”) rules by way of amendments to Implementing Regulation (EU) No 520/2012. The changes aim to clarify and strengthen certain pharmacovigilance obligations (some of which arguably reflect what is already the current practice and expectations of the EU PV inspectors).
The Regulation introduces a number of new compliance expectations and requirements for applicants and marketing authorisation holders (“MAHs”), some of which will start to apply before mid-August.Continue Reading Updates to the EU Pharmacovigilance Rules: Key Takeaways for Marketing Authorisation Holders
European Parliament backs reforms to the EU Regulatory Framework for Medicinal Products
Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 April.
The vote is a key step in the passage of the new Directive and Regulation, which together form the EU’s revisions to the General Pharmaceutical Legislation (GPL). These revisions are part of the overall EU pharmaceutical strategy that was announced by the European Commission in November 2020, with the core GPL amendments proposals published in April 2023.
With the vote, the European Parliament has now endorsed the position adopted by the Environment, Public Health and Food Safety Committee on 19 March 2024. The Committee had amended the Commission’s proposal in several respects. Overall, the Parliament’s amendments are aimed at encouraging and fostering more innovation in the EU, and industry will be pleased that some of its core concerns have been addressed, although significant areas of uncertainty remain.
The adoption of the package is likely to be delayed by the European Parliament elections in June this year. The reforms will be taken up by the new Parliament after the elections, and so it is difficult to see any agreement being reached before 2026.
Below is a summary of the Parliament’s position in some of the key area. This summary is, however, not exhaustive but rather highlights topics that have been subject to increased interest for industry and extensive discussions in the European Parliament.Continue Reading European Parliament backs reforms to the EU Regulatory Framework for Medicinal Products