Guidance Document - Development Safety Update Report (DSUR) - International Conference on Harmonisation (ICH) Topic E2F
Date Adopted: 2012/06/22
Effective Date: 2015/12/04
December 4, 2015
Our file number: 15-113089-994
Re: Health Canada's Implementation of the Development Safety Update Report Review
Health Canada has adopted the International Conference on Harmonisation (ICH) guidance E2F: Development Safety Update Report (DSUR) since June 2012. By way of this Notice, Health Canada is informing stakeholders that it has completed its pilot phase and is implementing its strategy for DSUR regulatory reviews in the Health Product and Food Branch (HPFB).
As of December 4, 2015, DSUR and the DSUR Checklist should be provided upon request, directly to the Office of Submission and Intellectual Property (OSIP). Health Canada recommends that DSURs in electronic Common Technical Document (eCTD) format be sent via the Common Electronic Submission Gateway (CESG) and DSURs in "non-eCTD electronic-only" format be sent to OSIP via compact disc/digital versatile disc (CD/DVD). (Refer to section 5 below for address of filing).
DSURs may be provided voluntarily by sponsors when important new safety information on a drug needs to be conveyed. In these cases, a strong rationale/justification for the filing of the DSUR should be included in the cover letter.
This Notice supersedes the Notice: Pilot project for the implementation of the Development Safety Update Report Regulatory Review at Health Canada published in 2012.
Objectives of DSUR Review at Health Canada
The objectives of the adoption of ICH E2F and DSUR review are to:
- Enhance the safety surveillance of drugs in development and protect clinical trial subjects;
- Analyze important identified and potential risks;
- Identify potential safety issues at the pre-approval stage;
- Support, when required, the safety assessment of drugs submitted for market authorization; and
- Support the life cycle approach to product vigilance.
The use of DSURs will allow Health Canada to better align with international best practices.
Scope of Products Covered by DSURs
DSURs will be accepted from clinical trial sponsors of human drugs covering the following product lines:
- Biologics and biotechnology products, including blood products and vaccines.
Types of Regulatory Activities affected by DSUR Review
DSUR should be submitted on request for the following regulatory activities:
- Clinical trials safety monitoring and assessments
- Submission review for marketing authorization.
The following Check list for Submitting Requested Development Safety Update Reports (DSUR) in Electronic Format should be completed and included with each DSUR provided to Health Canada.
Electronic documents on media should be sent to the Office of Submissions and Intellectual Property (OSIP).
Questions or comments regarding this notice should be directed to the following contacts:
Office of Clinical Trials
Therapeutic Products Directorate (TPD)
Office of Regulatory Affairs
Biologics and Genetic Therapies Directorate (BGTD)
Appendix - I
Instructions for Providing Requested Development Safety Update Reports (DSUR) in Electronic Format
Health Canada recommends that all DSURs should be provided in electronic format, preferably in eCTD format, however if not possible, sponsors should provide them in "non-eCTD electronic-only" format. No paper copy of the DSUR or the DSUR Checklist should be provided.
- When preparing a DSUR in eCTD format, refer to the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format. The following sections are the most relevant:
- Section 2.1 for cover letter requirements;
- Section 2.4.1 for the placement of documents in the structure;
- Section 3.2 for information about the transmission of electronic data.
- When preparing a DSUR in "non-eCTD electronic-only" format, refer the Guidance Document: Preparation of Drug Regulatory Activities in the "Non-eCTD Electronic-Only" Format. The following sections are the most relevant:
- Section 2.1 for cover letter requirements;
- Section 2.2.2 for the placement of documents in the structure;
- Section 3.3 for information about the transmission of electronic data.
Questions related specifically to Appendix - I should be directed to firstname.lastname@example.org.
This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and the United States of America.
In adopting this ICH guidance, Health Canada endorses the principles and practices described therein. This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidances.
Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations. They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.
Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this guidance, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
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