Implementation of International Council for Harmonisation (ICH) Q12 - Technical and regulatory considerations for pharmaceutical product lifecycle management: Notice
October 17, 2025
Our file number: 25-105890 – 674
As a standing regulatory member of the International Council for Harmonisation (ICH), Health Canada is committed to the adoption and implementation of all ICH guidance. By way of this Notice, Health Canada is advising of its intent to implement in a step-wise manner, ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and the ICH Q12 associated annexes. The initial scope of Health Canada's implementation of ICH Q12 will be only Post Approval Change Management Protocols (PACMPs) products regulated by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD). Established Conditions for all products and PACMPs for products not regulated by BRDD will not be applicable to the initial implementation. The target timeframe for the initial implementation of ICH Q12 has been set to December 2025. Subsequent implementation by the Pharmaceutical Drugs Directorate will follow with an implementation date to be communicated early 2026.
This guidance has been developed by the appropriate ICH Expert Working Group and has 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 membership of ICH. As part of the preparation for this initial implementation, Health Canada launched a stakeholder consultation in August 2021 to gather feedback on the final elements of the implementation of the Q12 guidance in Canada. Health Canada also launched pilot programs on: 1) Established Conditions and Post Approval Change Management Protocols, and 2) Immediate Notifications for Pharmaceuticals. The time taken since then has allowed Health Canada to deliver appropriate training, revise guidance documents and templates while adjusting its processes to account for ICH Q12 elements.
This Guideline provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Implementation of this guideline will promote innovation and continual improvement in the biopharmaceutical sector and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. It will allow regulators (assessors and inspectors) to better understand the firms' Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.
ICH Q12 should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances, such as the Guidance Document : Post-Notice of Compliance (NOC) Changes: Overall Quality Document and companion documents. This and other ICH Guidance documents are available on the ICH Website. 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.
Contact information
For any comments or inquiries related to this notice, please contact:
Health Canada – ICH Coordinator
E-mail: ich@hc-sc.gc.ca
Please include "Implementation of ICH Q12" in the subject line.