Implementation of a Risk-Prioritized Periodic Safety Update Report Regulatory Review Pilot, including the adoption of International Conference on Harmonisation (ICH) Guidance Clinical Safety Data Management
November 19, 2010
Our file number: 10-123674-389
Health Canada, as an official observer to, and active participant in, the International Conference on Harmonisation (ICH), is committed to the adoption and implementation of ICH guidance. By way of this Notice, Health Canada is advising of the recent implementation of a two (2) year pilot which takes a risk-prioritized approach for the review of Periodic Safety Update Reports (PSURs), including adoption of ICH Guidance Topic E2C for human drugs, as of April 1, 2010.
The risk-prioritized PSUR Regulatory Review Pilot (PSUR-RRP) will implement one of several program activities that deliver on Health Canada's strategic objectives (i.e. Blueprint for Renewal II) and the Government of Canada's commitments vis-à-vis, the Food and Consumer Safety Action Plan, that seek to better protect the health of Canadians by improving the ongoing monitoring (i.e. lifecycle management) of health product safety and effectiveness.
Scope of the PSUR-RRP
The PSUR-RRP will apply to voluntary PSUR submissions received from Market Authorization Holders (MAHs) for human drugs covering the following product lines:
- biologics and biotechnology products (blood products);
- radiopharmaceuticals; and,
- vaccines (therapeutic and preventative).
Objectives of the PSUR-RRP
Some types of information about a therapeutic product may not be available prior to marketing. The PSUR-RRP will enable Health Canada to take a more comprehensive lifecycle management approach to therapeutic products through the continuous monitoring and assessment of their benefit-risk profiles. Objectives include:
- earlier detection of potential health product safety issues;
- conformance to international product vigilance best practices;
- establishing performance metrics that will enable Health Canada to better determine the resources required to support ongoing PSUR review.
Risk-Prioritized Approach to PSUR Review
In this pilot phase, Health Canada will continue to accept voluntary PSUR submissions and/or those which are solicited in response to identified safety issues.
All PSURs submitted on a voluntary basis will be assessed by Health Canada and if specific safety issues are identified for individual products the MAHs may be requested to submit PSURs at established intervals, or until the assessment/monitoring of the safety issue has been resolved, or, a request is made to submit additional safety information (i.e. Requested Ad Hoc; or Requested Periodic).
Submissions of PSURs to Health Canada
As part of Health Canada's ongoing commitment for improved document management and control, all PSUR submissions will be processed and tracked using the Drug Submissions Tracking System (DSTS) currently managed by the Submission and Information Policy Division (SIPD) of the Therapeutic Products Directorate (TPD). It is recommended that PSURs be submitted as a stand-alone regulatory package separate from other information such as a Risk Management Plan (RMP) and post-approval commitments.
As per Guidance documents posted on the Health Canada Web site, currently there are two acceptable formats in which MAHs can file electronic PSUR submissions. The two formats are:
- Electronic submission in eCTD format
- Electronic submission in non-eCTD format
PSUR submissions in eCTD format on CD/DVD should be accompanied by a paper cover letter as announced in the Notice Increased Scope of Submissions being accepted in Electronic Common Technical Document (eCTD) Format and acceptance of electronic-only submissions, posted on Health Canada's Web site.
If PSUR submissions are not submitted in eCTD format, MAHs are recommended to submit them in electronic format as PDF files in accordance to the notice published on the Health Canada Web site in February 2008, Release of Health Canada's Revisions to "1.6 Electronic Review Documents" in Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format.
The electronic submission in PDF format is the legal document for PSUR submissions in the "non-eCTD format". The naming convention used for the PDF file is up to the MAH's discretion, however meaningful names should be applied. The CD/DVD including both the electronic copy of the PSUR and the cover letter should be accompanied by a paper cover letter. No paper copy of PSUR submissions should be submitted to Health Canada.
As of October 31, 2010 MAHs are required to submit PSURs and related information directly to SIPD using the following address:
Submission and Information Policy Division
Therapeutic Products Directorate
Postal Locator 0201A1
101 Tunney's Pasture Driveway
Ottawa, ON K1A 0K9
For inquiries related to electronic submissions, please contact Health Canada using the following e-mail address:
For inquiries related to this notice, please contact Health Canada using the following address:
Risk Tool Screening Section,
Office of Risk Management and Science
Marketed Health Products Directorate
Postal Locator 0701L
200 Tunney's Pasture Driveway
Ottawa, ON K1A 0K9
Or, by mail at the following e-mail address:
All enquires pertaining to this Notice should include the statement, "Implementation of PSUR Reporting" in the subject line.
Additional information can be found in the document Questions and Answers Regarding the Implementation of a Risk-Prioritized Periodic Safety Update Report Regulatory Review Pilot (PSUR-RRP) at Health Canada available on the Health Canada Web site.
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