22 August 2025 – Swissmedic has launched the public consultation on Guideline Q3E of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines). The deadline for comments is 18 December 2025.

Currently, there is no internationally harmonised guidance on Extractables and Leachables (E&L) assessment and control. Additionally, a lack of alignment, consensus and clarity among existing guidelines, pharmacopeial standards and other standards addressing E&L further generates uncertainty for the industry and regulators. Therefore, besides other, the proposed new quality guideline includes chemical, biological and biotechnological products, as well as cell- and gene therapy products.

For more information, see here.