Latest Posts:
Search for:
Author

Baker McKenzie - HiH Blog

Browsing
In Medical Devices

EU Biotech Act Unveiled: Commission’s Proposal to Turn Europe into a Biotech Powerhouse

by 7 Mins Read

Background On 16 December 2025, the European Commission published its long-awaited Proposal for a Biotech Act with an aim to “build a world-leading health biotech industry” and transform Europe into a “Biotech Powerhouse”. The Proposal recognises that the EU is losing ground to global competitors such as the US and China in developing innovative biological products and identifies insufficient funding, regulatory bottlenecks, and barriers to innovation as key obstacles limiting the EU’s ability to compete…

Read More
In EU Pharmaceutical Package

EU Pharma Package: A Landmark Political Deal Sealed

by 5 Mins Read

In the early morning of 11 December 2025, the Council and European Parliament reached a political agreement on the overhaul of the general EU pharmaceutical legislation (the “Pharma Package”) consisting of a new Regulation replacing current Regulation (EC) No 726/2004, and a new Directive replacing current Directive 2001/83/EC. This is the first major reform in over 20 years, and it comes nearly three years after the Commission’s initial proposal was published in April 2023. The…

Read More
In Healthcare Services

European Commission’s Actions to Prevent Medicine Shortages in the EU

by 4 Mins Read

On 24 October 2023, the European Commission issued a communication setting out short-term and medium/longer-term actions to prevent or mitigate critical shortages at EU level, with a particular focus on the most critical medicines for which supply needs to always be assured in the EU. Actions to be taken in the short term include the following: In the medium/longer-term, the Commission intends to set up a Critical Medicines Alliance by early 2024, allowing national authorities,…

Read More
In Digital Health

EU Clinical Trial Information System (CTIS) Becomes Mandatory

by 3 Mins Read

In brief Starting from 31 January 2023, the Clinical Trial Information System (CTIS), provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area (EEA) countries. Key takeaways The single portal was launched on 31 January 2022, initiating the one-year transition period during which sponsors could choose whether to submit a clinical…

Read More
In Medical Devices

Italy: National Coordination Centre for Ethics Committees updates the documentation relating to clinical trials and investigations

by 4 Mins Read

In brief On 10 November 2022, the National Coordination Centre for Ethics Committees (“Centre”) published the updated versions of the “Contract for the performance of clinical trials on medicines,” the “Contract for the performance of independent clinical trials on medicines” and the “Contract for the performance of clinical investigations on medical devices that are not CE marked or CE marked but used outside their intended use.” Key takeaways In particular, the updates relate to: (i)…

Read More
In Medical Devices

The European Commission Adopts Implementing Regulation on Reclassification of Groups of Certain Active Products Without an Intended Medical Purpose

by 3 Mins Read

In brief On 1 December 2022, Implementing Regulation EU 2022/2347 on the reclassification of groups of certain active medical devices without an intended medical purpose, as listed in Annex XVI to Regulation EU 2017/745, was published in the Official Journal of the EU. Key takeaways The Implementing Regulation introduces an exception to the general rule, according to which active devices that are not included in a particular risk class according to the classification rules fall…

Read More