On August 6, 2021, Health Canada issued five draft revised Guidance Documents on Post-Notice of Compliance (NOC) Quality Changes for stakeholder consultation. The proposed draft guidances, which are only available upon request, are as follows:
- Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
- Post-Notice of Compliance (NOC) Changes: Overall Quality Document
- Post-Notice of Compliance (NOC) Changes: Quality - Guidance for Human Pharmaceuticals
- Post-Notice of Compliance (NOC) Changes: Quality - Guidance for Biologics
- Post-Notice of Compliance (NOC) Changes: Quality - Guidance for Schedule C drugs
Interested stakeholders should follow the link here to request copies of the draft documents.
The draft guidances are intended to provide a systematic approach for sponsors seeking to make post-approval changes to drugs, as per section C.08.004 of the Food and Drug Regulations. When determining the categorization of post-approval changes, Health Canada recommends sponsors consider whether the established conditions described therein are met. As with the current version of the guidance, Health Canada also provides recommendations for documentation to support the change.
Currently, the Post-NOC Changes - Quality guidance exists as a single document with four appendices. Health Canada is now proposing to divide this guidance into four separate documents: an overall quality document and a separate guidance each for Human Pharmaceuticals, Biologics, and Schedule C drugs. In addition, the draft guidances introduce a new reporting category, Level III - Immediate Notifications, and provide definitions to distinguish Level III - Immediate Notifications from Level III - Annual Notifications. The revised Framework document notes that supporting documentation for Level III - Immediate Notifications should be filed within 15 days of the date when the product which is manufactured using that change is first released to the Canadian market. In contrast, data supporting Level III – Annual Notifications should not be submitted, but should be available upon request, which is consistent with current filing requirements for Level III - Annual Notifications.
In current practice, sponsors are not required to submit Certified Product Information Document-Chemical Entities (CPID-CEs) for Level III - Annual Notifications. The draft revised guidance documents, however, introduce a new requirement for submission of CPID-CEs with Level III change notifications (i.e. Immediate and Annual Notifications) for pharmaceuticals.
In light of these substantial changes, Health Canada has opened a consultation period to solicit comments from industry stakeholders, who may submit their comments to hc.policy.bureau.enquiries.sc@canada.ca until November 4, 2021. In the meantime, although current requirements remain unchanged, industry stakeholders should remain on the lookout for additional notices or guidance on a pilot process of the Level III - Immediate Notification category, which is expected to launch later this year.
Author: Lydia To
References:
- Notice: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-release-draft-revised-guidance-documents-post-notice-compliance-changes-quality.html
- Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation. https://www.canada.ca/en/health-canada/programs/release-draft-revised-guidance-documents-post-notice-compliance-changes-quality.html