Health Canada is consulting on revised guidance of Post-Notice of Compliance (NOC) Changes – Quality.
Draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality have been released for stakeholder consultation.
Who is the focus of the consultation?
- Sponsors of pharmaceutical, biologic or radiopharmaceutical drugs
- Academia
About the Quality guidance under consultation
- The Post-Notice of Compliance (NOC) Changes – Quality Guidance was originally released in September 2009
- It provides comprehensive guidance regarding the conditions for the categorisation of common post-authorisation changes and recommendations for supporting documentation.
- The guidance was a single document with four appendices specific to different product lines.
- The guidance has now been updated and for ease of reference, it has been split into (4) four separate documents plus a framework document 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
The revised Framework document also provides information relevant to post-Notice of Compliance changes related to safety.
Further details on the above documents is available here.
According to Health Canada, the draft documents are only available upon request due to their format, This seems to be an unusual approach and has the scope to hinder the consultation since respondents are much more likely to respond if the documents are made available on the website, rather than having to ask for them proactively.
What are the start and end dates of the consultation?
Start date 6 August 2021
End date: 4 November 2021
Source: Health Canada website