New Restriction on Substances D4, D5, and D6: Impact on Medical Devices
New Restriction on Substances D4, D5, and D6: Impact on Medical Devices Regulation (EU) 2024/1328 of 16 May 2024 amends Annex XVII of the REACH Regulation by introducing significant restrictions on the use of octamethylcyclotetrasiloxane (D4),...
Advanced Materials in Europe: a need for regulatory clarity
Differences between Advanced Materials and Nanomaterials Advanced materials (AdMat) are materials designed to offer superior properties to conventional materials. They are defined by their performance and functionality and are distinguished by: Their specific...
Medicines and the environment: the EMA’s new framework
The 2024 revision of the EMA guideline on the environmental risk assessment (ERA) of human medicinal products (EMA, 2024)[1] replaces practice-based approaches with a clear, harmonised methodology. It retains the tiered approach introduced in 2006, clarifies how it...
When a Micro-Story Illustrates Macro-Regulatory Challenges: A Look Back at the Chromium Trioxide Case
Exactly one year ago, the Paris 2024 Olympic Games came to a close, symbolised by the medals awarded to athletes. Yet by January 2025, more than a hundred bronze medals were already showing visible signs of deterioration(1). The reason: a failure in surface treatment....