The European Commission (EC) began a public consultation on August 4, 2025, on the European Biotech Act in the form of an online questionnaire. According to the EC, the aim is to gather evidence and views from stakeholders...more
The UK government (the “Government”) has published proposals for a new regulatory framework for artificial intelligence (the “White Paper”). Its goal is to “provide a clear, pro-innovation regulatory environment” to make...more
Reducing sources of counterfeit or grey market goods is a perennial challenge for every brand owner. Recent parallel developments in the EU and the US show how legislators are tackling the issue of counterfeit goods on online...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
On February 19, 2020, the European Commission (“EC”) published a series of documents outlining its vision for Europe’s digital future. Amongst these, the EC’s White Paper on Artificial Intelligence: A European approach to...more
On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of the EMA’s Patient Registries...more