Swissmedic launches the public consultation on Guideline Q3E of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines), with a deadline of 18 December 2025 for comments.
Public consultation for ICH Guideline Q3E “Guideline for Extractables and Leachables” launched in Switzerland
22.08.2025
Stakeholders in Switzerland have the opportunity to comment on the draft Guideline Q3E “Guideline for Extractables and Leachables” until 18 December 2025.
ICH has developed guidelines covering many aspects of impurities. These include process- and product-related substances (Q3A, Q3B), residual solvents (Q3C) and new guidelines covering elemental (Q3D) and mutagenic (M7) impurities.
However, no internationally harmonised guidance on Extractables & Leachables (E&L) assessment and control exists; there is a current lack of alignment, consensus and clarity among existing guidelines, pharmacopeial standards and other standards addressing E&L. This lack of clarity regarding E&L is generating uncertainty for the industry and regulators as to whether regulatory expectations are being met.
The scope of the proposed new quality guideline will include:
- Chemical, biological and biotechnological products, as well as drug-device combination drug products.
- Cell- and gene therapy products
- All associated dosages forms, taking into account the extracting/leaching conditions, the route of administration, drug indication and patient exposure.
Comments can be sent using the feedback form specified by ICH to networking@swissmedic.ch. Stakeholders will receive confirmation of receipt of their comments, but no feedback on the individual comments. Once the public consultation phase has been completed, the comments submitted will be discussed in the responsible ICH working group and taken into account where appropriate.
Links to the guideline and feedback form can be found at: