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 :
- reduce regulatory issues and roadblocks to innovation
- make Canada's science-based regulatory system more agile
- bring our regulatory system in line with international approaches
As part of the Agile regulatory package, the following amendments were made:
- Where a manufacturer uses a manufacturer's standard for a new drug (i.e. a drug regulated under Part C, Division 8 of the FDR), the Regulations exempt them from having to meet the most stringent limits for purity and potency of all the Schedule B pharmacopoeias in which the active ingredient or drug appears. This allows those manufacturers who use a manufacturer's standard to have different limits for purity and potency than the most stringent listed under Schedule B, that are acceptable to the Minister. This exemption does not apply to new drugs regulated under Schedule C (radiopharmaceutical drugs). Manufacturers who use a manufacturer's standard for drugs that are not new drugs will continue to be required to meet the most stringent limits for purity and potency of all the Schedule B pharmacopoeias.
- For all drugs, other than those regulated under Part C, Divisions 3 and 4 (i.e. radiopharmaceuticals and biologics) of the FDR, the Regulations remove the requirement for the standard used for the drug to be indicated on the package label.
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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