Several recent finalized ICH guidelines have been released in the last 12 months. Of importance for the types of products we represent at Cosmetics Alliance are:
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Jan 12, 2026)
Q14 Analytical Procedure Development (Jan 12, 2026)
Q2(R2) Revision of Analytical Validation
Q13 Continuous Manufacturing of Drug Substances and Drug Products
Q3C(R9) Impurities: Residual Solvents
As a reminder, several of these revised guidance documents include links to Q&A documents and/or presentations on the topics.
A full list of the recently revised ICH guidance documents which have been or will be implemented may be found here.
Some existing Health Canada guidance may not fully align with newly adopted ICH guidelines. In such cases, Health Canada–implemented ICH guidelines take precedence. Health Canada will address these discrepancies through stakeholder notices, which may result in the amendment or withdrawal of certain guidance documents.
