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

From Health Canada

Current status: Open

Opened on August 6, 2021 and will close to new input on November 4, 2021.

Stakeholders are invited to comment on draft revised guidance documents on Post-Notice of Compliance (NOC) Changes - Quality, for pharmaceutical, biologic and radiopharmaceutical drugs for human use. Comments will be considered in finalizing the documents. For more information, please see the accompanying Notice.

Join in: how to participate

For copies of draft documents, email hc.bpsip-bpspiconsultation.sc@canada.ca with the subject line "Post NOC changes Quality documents English".

  1. Send us an email
    Send an email to E-mail: hc.policy.bureau.enquiries.sc@canada.ca with your comments
  2. Participate by mail
    Send a letter with your input to the address in the contact information below.

Who is the focus of this consultation

We will engage with:

Key questions for discussion

Health Canada's 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. This document has been updated, and for ease of reference, it has now been split into (4) four separate documents; one each for human pharmaceuticals, biologics and Schedule C drugs (radiopharmaceuticals) 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. Documents related to drugs for veterinary use will be published separately.

Your input is sought on the following draft guidance documents:

  1. Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
  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 input gathered through this process will be analysed and considered in finalizing the guidance documents.

Contact us

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

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

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