Guidance on post-notice of compliance (NOC) quality changes to drugs for human use: Consultation closed

From Health Canada

Stakeholders were invited to comment on draft guidance documents on post-notice of compliance (NOC) quality changes for pharmaceutical, biologic and radiopharmaceutical drugs for human use. Health Canada will consider the comments when finalizing the documents.

Who was the focus of this consultation

We engaged with:

• Sponsors of pharmaceutical, biologic or radiopharmaceutical drugs
• Academia

Key questions for discussion

Health Canada's guidance on post-notice of compliance (NOC) quality changes, released in September 2009, helps stakeholders understand the conditions for categorizing common post-authorization changes. Our guidance also offers recommendations for supporting documentation. Our 2009 guidance was split into the documents mentioned below.

We sought stakeholder input on the framework document and the following 4 separate draft documents on:

• overall quality
• biologics
• pharmaceuticals
• Schedule C drugs (radiopharmaceuticals)

The draft document on veterinary drugs was not part of the consultation.

Based on the feedback, we are updating the framework and the 4 draft documents.

The revised framework also provides information relevant to post-NOC changes on safety. We will publish documents related to drugs for veterinary use separately.

Contact us

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs 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