US President Donald Trump told reporters last week that pharma tariffs are coming “sometime in the near future”.

Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments ...

The success in intra-European healthcare deals requires regulatory expertise, operational flexibility and market-specific ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has ...

March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming ...

Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is ...

EU member states are set to launch the EU Health Data Space Regulation for harmonised data transfer on 26 March.

The integration of AI and cloud technologies is transforming pharmaceutical manufacturing regulations, focusing on safety, efficiency, and global harmonization.

European Union's digital resilience. Compliance with these regulations is not only a legal imperative, but also a factor that ...

Enable is currently working with a number of pharmaceutical partners to conduct clinical trials and plan for joint commercial launch of their therapies in combination with the enFuse technology. The ...

In January 2025, hygh-tec Odor Solution™ received 510(k) clearance from the United States Food and Drug Administration (FDA) and certification under the European Medical Device Regulation (MDR), ...

The European Commission has clarified its position on mandatory USB-C charging for portable devices. The law does allow for devices to ditch wired charging entirely, as long as it supports a ...