Notice: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation

August 6, 2021
Our file number: 21-113843-585

Health Canada is pleased to announce the release of five associated revised draft guidance documents on Post-Notice of Compliance (NOC) Quality Changes for pharmaceutical, biologic and radiopharmaceutical drugs for human use, for stakeholder consultation.

The documents are as follows:

1. Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use)
2. Post-Notice of Compliance (NOC) Changes: Overall Quality Document
3. Post-Notice of Compliance (NOC) Changes: Quality - Guidance for Human Pharmaceuticals
4. Post-Notice of Compliance (NOC) Changes: Quality - Guidance for Biologics
5. Post-Notice of Compliance (NOC) Changes: Quality - Guidance for Schedule C drugs

The Post-Notice of Compliance (NOC) Changes - Quality Guidance released in September 2009 provides comprehensive guidance regarding the conditions for the categorization of common post-authorization changes and recommendations for supporting documentation. The guidance was a single document with four (4) appendices specific to different product lines. For ease of reference, this document has now been split into (4) four separate documents; one each for human pharmaceuticals, biologics and Schedule C drugs and an overall document which covers aspects common to these three guidance documents. The revised Framework document also provides information relevant to post-Notice of Compliance changes related to safety.

Note that documents related to drugs for veterinary use will be published separately.

The Framework document has been revised to include the (4) four documents.

In brief, the revisions include changes to the following:

Framework document

• Introduction of a Level III Immediate Notification reporting category, including when these Notifications are to be submitted and the supporting data to be filed with Level III form, as applicable
• New definitions for Annual and Immediate Notifications

Overall document

Introduction of ICH Q12 tools and elements, including established conditions, post-approval change management protocols and product lifecycle management document. Note that although the ICH Q12 concepts and elements are incorporated in the guidance document, full implementation of ICH Q12 is targeted for the end of 2021/early 2022. Activities regarding the implementation plan will be communicated to the stakeholders in the coming months, including the possibility of a pilot program.

Pharmaceuticals for human use document

• Introduction of a new reporting category - Immediate Notifications
• Clarification of the conditions to be fulfilled, the reporting categories and the supporting data for Supplements, Immediate and Annual Notifications

Biologic and Schedule C drugs documents

• Clarification and minor revisions to conditions and required supporting data

For details, refer to the individual documents, including Document Change logs.

Due to their format, the draft documents are only available upon request.

If you have an email client installed on your computer, when you click the link below, an email message should appear with some information pre-filled; Simply 'Send' this message.

hc.bpsip-bpspiconsultation.sc@canada.ca

If an email message does not appear, send an email to hc.bpsip-bpspiconsultation.sc@canada.ca , and request the documents. Please ensure the text "Post NOC changes Quality documents English" is in the subject line of the email.

Comments should be provided to Health Canada within 90 days of the publication of this Notice. All comments will be taken into consideration in finalizing these documents.

The Immediate Notification category will be subject to a pilot process by the Therapeutic Products Directorate later this year. Separate guidance related to the piloting of this category will be published prior to the pilot process.

Please note that until such time as these guidances are finalized and published, current requirements remain unchanged and proposals in the draft guidances are not to be implemented.

Comments should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2^nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca