Health Canada has updated guidances concerning pre and post-licensing submissions and performance standards for PDCs for prescription pharmaceutical drugs and those administered or obtained through a health professional.
Notice: Revision to the Guidance Document Management of Drug Submissions and Applications
Health Canada is revising the Guidance Document entitled The Management of Drug Submissions and Applications (MDSA).
This document:
- provides operational direction and guidance regarding the way in which drug submissions, applications or post-market documents submitted to Health Canada are managed to the following:
- sponsors and Health Canada staff of the Pharmaceutical Drugs Directorate
- the Biologic and Radiopharmaceutical Drugs Directorate
- the Natural and Non-Prescription Health Products Directorate (Non-Prescription Drugs Evaluation Division
- Marketed Health Products Directorate
- outlines and describes the processes and procedures to be followed to ensure consistency and transparency in the management of information and material submitted by sponsors to Health Canada in accordance with the Food and Drugs Act & Food and Drug Regulations
The guidance is being updated to reflect the following:
- Defining the duration of a response to clarification request.
- Removing the Submission Certification requirement for Responses to Submission Deficiency Notice (SDN), Notice of Deficiency (NOD) and Notice of Non-Compliance (NON).
- Reflecting the updates made to the performance standards for Post-authorization Division 1 Changes (PDCs) for prescription pharmaceutical drugs and those administered or obtained through a health professional in the Guidance Document: Post-Drug Identification Number (DIN) Changes.
The updated guidance is effective from 2 August 2022.
Source: Health Canada
Post-Drug Identification Number (DIN) Changes Guidance Document
All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a Drug Identification Number (DIN).
- After gaining authorization to market a drug a sponsor may for various reasons wish to make changes to the drug or the information associated with the drug.
- The guidance is intended to advise both internal and external stakeholders regarding the filing requirements for postmarket changes and the data recommendations to support those changes.
The update concerns a Policy Change to the performance standards of Post-DIN Changes (PDCs) for human prescription pharmaceuticals and those administered or obtained through a health professional
Administrative changes have been made to:
- replace names and dates of guidance documents with the most recent version
- add new guidance documents not previously included
- change the Therapeutic Product Directorate (TPD) to the Pharmaceutical Drugs Directorate (PDD)
The updated guidance is effective from 2 August 2022. The complete guidance can be viewed here or downloaded as a PDF here.
Source: Health Canada
Notice: Revisions to the performance standards for Post-authorization Division 1 Changes
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.
The revisions are as follows:
1) Performance standard for PDCs-prescription drugs that require an assessment by the Pharmaceutical Drugs Directorate (PDD)
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:
- 25 day screening and a 120 day review for Safety PDCs, and
- 25 day screening and a 90 day review for Quality PDCs.
2) Administrative PDCs for prescription pharmaceuticals
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 from 2 August 2022. Any forms, databases, guidance documents and processes affected by this change have been revised accordingly.
Source: Health Canada