Notice – Interim Implementation of International Council for Harmonisation (ICH) Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

October 9, 2020
Last update: November 29, 2021
Our file number: 20-113699-873

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 ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and the ICH Q12 associated annexes. 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. The target timeframe for Health Canada implementation of ICH Q12 has been set to the third quarter of 2022 in order to allow sufficient time for the preparation of regulators and stakeholders. 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 has also launched pilot programs on: 1) Established Conditions and Post Approval Change Management Protocols, and 2) Immediate Notifications for Pharmaceuticals.

This new Guideline is proposed to provide 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 new ICH 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. 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

Please include "Implementation of ICH Q12" in the subject line.

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