Notice: Revisions to the performance standards for Post-authorization Division 1 Changes
August 2, 2022
Our file number: 22-107706-88
Health Canada is revising the performance standards for Post-authorization Division 1 Changes (PDCs) for prescription pharmaceutical drugs and those administered or obtained through a health professional. The performance standards for non-prescription pharmaceuticals PDCs and disinfectant PDCs will remain unchanged.
As per Section C.01.014.4 of the Regulations, post-DIN changes require either the filing of a new DIN application or a Notification. The Pharmaceutical Drugs Directorate (PDD) manages PDCs for prescription pharmaceuticals and those administered or obtained through a health professional using:
- the Guidance Document: Post-Drug Identification Number (DIN) Changes (2013),
- the Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs document, and
- the Post-Notice of Compliance (NOC) Changes guidance documents.
The performance standard for PDCs-prescription drugs that require an assessment by the Pharmaceutical Drugs Directorate (PDD) will change from a 30-day screening (which includes review) to a:
- twenty five day screening and a 120 day review for Safety PDCs, and
- twenty five day screening and a 90 day review for Quality PDCs.
The administrative PDCs for prescription pharmaceuticals will remain as 45 days (administrative screening).
These changes are being made as performance data shows the 30-day PDC timeline for prescription pharmaceuticals is not adequate for the effort required to screen and review these changes. Reasons for this include:
- Some clinical or quality PDCs submitted for older pharmaceuticals require a more in-depth review of outdated labelling to bring them up to an acceptable standard for safe use.
- The current PDC timeline established in December 2009 does not provide adequate time to review PDCs in accordance with the Plain Language Labelling regulations that came into force in June 13, 2015.
- Some PDCs are complex and require more research that is intensive in screening and possibly a clinical/quality consult.
- When multiple information requests (clarifaxes) are sent to sponsors with a 15-day response time for each clarifax, the review would not be completed on time; therefore, sponsors are asked to respond to a clarifax within five days. For global drug companies, meeting this timeline is challenging and can be further complicated by different time zones.
To identify separate performance standards for the different types of pharmaceuticals PDCs in the Drug System Tracking System (DSTS) and the Guidance Document: Management of Drug Submissions and Applications, the current PDC class is replaced with the following three classes: PDC-prescription, PDC-non-prescription and PDC-disinfectant.
The increased performance standards for PDC-prescription pharmaceuticals and those administered or obtained through a health professional becomes effective immediately. Any forms, databases, guidance documents and processes affected by this change have been revised accordingly.
Questions or concerns should be directed to:
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate, Health Products and Food Branch
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