Post-notice of compliance changes
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Overview of Health Canada's implementation of ICH Q12 and Q14
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. Health Canada is advising of its implementation in a step-wise manner, of ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, the ICH Q12 associated annexes and ICH Q14: Analytical Procedure Development.
The initial scope of Health Canada's implementation of ICH Q12 is only Post Approval Change Management Protocols (PACMPs) for products regulated by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD). Established Conditions (ECs) for all products and PACMPs for products not regulated by BRDD will not be applicable to the initial implementation. Associated revisions to the Guidance on Post-Notice of Compliance Changes: Overall Quality Document for Biologic and Schedule C Drugs for Human Use and companion documents have been published. The submission of PACMPs to BRDD will be accepted following a 90 day coming into effect period on August 13, 2026. Subsequent implementation of ICH Q12 by the Pharmaceutical Drugs Directorate (PDD) will follow with an implementation date to be communicated in 2026.
The initial scope of Health Canada's implementation of ICH Q14 will not include ECs, in alignment with the implementation of ICH Q12. The use of ECs for analytical procedures in ICH Q14 is optional. In this framework, sponsors may propose ECs and associated reporting categories to regulatory authorities, subject to approval, but are not required to define ECs under the minimal approach. The implementation of ECs as part of Health Canada's implementation of ICH Q12 and Q14 will be further communicated to stakeholders in the future.
These guidances 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 their implementation by membership of ICH.
ICH Q12 and Q14 should be read in conjunction with the relevant sections of other applicable Health Canada guidances, such as the Guidance on Post-Notice of Compliance Changes: Overall Quality Document for Biologic and Schedule C Drugs for Human Use and companion documents. ICH Q12 and other ICH guidance documents are available on the ICH Website. 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, send an email to ich@hc-sc.gc.ca.
Guidance documents
Biologics and Schedule C drugs
- Guidance on post-notice of compliance changes: Framework for biologic and Schedule C drugs for human use [2026-05-15]
- Guidance on post-notice of compliance changes: Overall quality document for biologic and Schedule C drugs for human use [2026-05-15]
- Guidance on post-notice of compliance changes: Quality for biologics [2026-05-15]
- Guidance on post-notice of compliance changes: Quality for Schedule C drugs [2026-05-15]
- Certified Product Information Document – Biologics (Schedule D Drugs) (CPID-B(Schedule D Drugs) in the CTD Format [2024-06-04]
Pharmaceuticals
- Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical drugs for human use only) [2020-03-30]
- Guidance Document - Post-Notice of Compliance Changes: Quality Document [2019-07-31]
- Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form (PDF fillable/saveable (435 KB)) Download form to your desktop before filling out.) [2020-04-01]
Safety and efficacy
Contact information
For any comments or inquiries, contact:
Health Canada – ICH Coordinator
E-mail: ich@hc-sc.gc.ca