International Council for Harmonisation (ICH)
Guidelines: (Efficacy, Multidisciplinary, Quality, Safety)
On this page:
- Information on recently finalised ICH guidelines
- Recently finalised ICH guidelines
- Efficacy guidelines
- Multidisciplinary guidelines
- Quality guidelines
- Safety guidelines
Information on ICH guidelines implemented by Health Canada
The tables below outline the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) guideline(s) implemented by Health Canada. These guidelines have been developed by the appropriate ICH Expert Working Groups and have been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by the membership of ICH.
In implementing these ICH guidelines, Health Canada endorses the principles and practices described therein. Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox.
It is recognized that the scope and subject matter of current Health Canada guidance documents may not be entirely consistent with those of the ICH guidelines that are being introduced as part of our commitment to international harmonisation and the ICH Process. In such circumstances, Health Canada-implemented ICH guidelines take precedence.
Health Canada is committed to eliminating such discrepancies and will publish explanatory notices for stakeholders, where applicable. This will result in the amendment or, depending on the extent of revisions required, withdrawal of some Health Canada guidance documents.
Should you have any questions or comments regarding the contents of the ICH guidelines, please contact:
Health Canada - ICH Coordinator
Recently finalised ICH guidelines
This table lists ICH guidelines that have recently been finalised at ICH and are pending implementation or have either been implemented by Health Canada in the last 12 months.
|Document||Type of Notice||File Number||Additional Notes|
|Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management||Interim Implementation||20-113699-873||For more information, please see the October 9, 2020 Notice.|
|Q12: Pilot Programs||Notice||21-115313-479||N/A|
|E8(R1): General Considerations for Clinical Studies||Step 4 – Final Guideline||21-121043-747||This guideline was implemented on January 14, 2022|
|E14/S7B: Questions & Answers - Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential||Step 4 - Final Q&A Document||22-105019-395||This Q&A document was implemented on June 10, 2022|
|Q3D(R2): Revision of Q3D(R1) for cutaneous and transdermal products||Step 4 - Final Guideline||22-105313-723||This guideline was implemented on August 29, 2022|
|M10: Bioanalytical Method Validation and Study Sample Analysis||Step 4 - Final Guideline||22-108195-929||This guideline was implemented on January 20, 2023|
|M10: Questions & Answers - Bioanalytical Method Validation and Study Sample Analysis||Step 4 – Final Q&A Document||22-108195-929||This Q&A document was implemented on January 20, 2023|
Report a problem or mistake on this page
- Date modified: