BioTalk

The EU Pharma Package: Broader Bolar – Same Battleground?   The Bolar exemption (“Bolar 1.0”) determines the extent to which preparatory...

The UK government delivered its Autumn Budget on 28 October 2026. At first sight, the Budget contains relatively few announcements...

The Government’s consultation confirms that CE recognition for medical devices is here to stay, but the future role UKCA-marking will...

On 28 September 2026, the CEPS (French Pricing Authority) entered into a new framework agreement, with the LEEM (the leading trade...

This article is part of a series on the final agreement reached regarding the pharmaceutical package, which is currently awaiting formal...

The National Commission into the Regulation of AI in Healthcare, established by the Medicines and Healthcare products Regulatory Agency...

Following our recent BioTalk article, Ambient Scribing in the NHS: A Compliance Framework Suppliers Cannot Ignore (30 July 2026), a...

After more than two years of intense legislative debate, the EU institutions reached an agreement on the EU Pharma Package – the most...

The Court of Justice of the European Union (CJEU, 2 July 2026, Case C-427/24, Diagramm Halbach) has recently issued an important judgment...

After more than two decades, the legal architecture governing medicinal products in the European Union is being fundamentally rebuilt....

Your pipeline asset took years to develop. The partnership that was supposed to bring it to market has broken down. Now a tribunal needs...

A UK judge has for the first time granted a website blocking injunction targeting counterfeit and unlicensed prescription-only medicines....

The United States has introduced sweeping new tariffs targeting patented pharmaceutical products and their ingredients, with duties set...

Following our recent coverage of the new US tariffs on pharmaceutical imports, it is worth noting that Europe is also seeing significant...

  1. Introduction On 12 December 2025, the European Data Protection Board (EDPB) hosted a focused stakeholder event to gather input for...

Understanding the impact of the European Accessibility Act on Medical Devices The European Accessibility Act (Directive (EU) 2019/882)...