The European Commission announced today (16 December) its plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices (“IVDs”). Many industry stakeholders have criticized the current EU device rules as being slow, costly, unpredictable, and unnecessarily complex. Under the proposed revisions, the Commission
Continue Reading European Commission Announces (Long Awaited) Proposal to Simplify EU Medical Device RegulationsIn a landmark judgement, the Higher Regional Court of Cologne has set new standards for pharmaceutical advertising with influencers. First, a key point from the decision is that the court qualifies paid influencers as agents of the drug company with respective consequences for the company (discussed below). Second
Continue Reading Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media
At just after 5 am on 11 December 2025, the EU Parliament and the Council reached agreement on a new directive and a new regulation that will result in a major update to the EU’s pharmaceutical laws. Progress towards these new rules began in 2016 and are the result of
Continue Reading EU Announces Political Agreement on Pharma Law Review
On 1 December 2025, the UK Government announced a “landmark” UK-US pharmaceutical deal. Under the deal, the UK claims to be (so far) the only country to secure zero-percent tariffs on pharmaceuticals exported to the US for the next three years. In return, the UK has committed to increase its
Continue Reading Landmark UK-US Pharmaceutical DealOn September 17, 2025, the German Supervisory Authorities (Konferenz der unabhängigen Datenschutzaufsichtsbehörden des Bundes und der Länder, DSK) published new guidelines and recommendations addressing the complex requirements for transferring personal data, particularly health data (including health data contained in biomaterials), to countries outside of the European Economic
Continue Reading New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical ResearchArtificial Intelligence (“AI”) continues to command attention as today’s prominent technological asset, revolutionizing key markets and sectors. Simultaneously, discussions of another advanced technology known as quantum computing have gained traction. Because both technologies expand the universe of problems that can be tackled by computers, one might wonder, if we have AI, do we also need quantum computing technologies? In this article, we will discuss quantum computing and how it complements AI, including its ability to enhance AI models, and conversely, also explore AI’s ability to strengthen the power of quantum computing.Continue Reading Harnessing the complementary power of AI and Quantum Computing
Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in
Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon
On 31 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) issued a statement of policy intent relating to a service to provide early access to the Great Britain market for innovative medical devices (“Early Access Service”). Although this statement is non-binding, it indicates further efforts by the MHRA to reduce unwarranted barriers to market entry, through faster, risk-proportionate, and predictable routes to regulatory approval – in line with Action 25 of the Life Sciences Sector Plan (published on 16 July 2025).Continue Reading MHRA Issues Statement of Policy Intent Regarding Early Access to Innovative Medical Devices
On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published the outcome of its most recent medical device-related consultation. The MHRA also announced its intention to consult further on the indefinite recognition of CE-marked medical devices in Great Britain, with this consultation expected to take place later in 2025.Continue Reading MHRA Announces Consultation Response on Reforms to GB Pre-Market Medical Device Regulation
On July 7, 2025, the European Commission presented its Roadmap Towards Nature Credits, setting the blueprint for biodiversity certification in the EU. The Communication was also accompanied by a Q&A and a call for feedback by 30 September 2025.
In short, nature credits
Continue Reading An EU Biodiversity Market by 2027? The new EU’s Roadmap towards Nature Credits