Notice to stakeholders – Publication of updates to the Quality (Chemistry and Manufacturing) guidance: New drug submissions and abbreviated new drug submissions & the guidance document: Labelling of pharmaceutical drugs for human use documents

December 18, 2024
Reference number: 24-111345 - 492

There are new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations. These amendments were introduced through the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) regulatory package and are part of Health Canada's modernization work.

The amendments will :

As part of the Agile regulatory package, the following amendments were made:

As a result of these amendments, updates have been made to the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions and Abbreviated New Drug Submissions and the Guidance document: Labelling of pharmaceutical drugs for human use documents to reflect these amendments. In addition, changes have been made to the former guidance to update the information in relation to nitrosamines.

Contact information

For any questions or inquiries related to this notice, please contact:

Bureau of Policy, Science and International Programs
Pharmaceutical Products Directorate
Health Products and Food Branch
Health Canada
E-mail: hc.policy.bureau.enquiries.sc@canada.ca

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