Regulatory Focus™ > News Articles > Health Canada Launches Safety Pilot for Pharmaceuticals and Biologics

Health Canada Launches Safety Pilot for Pharmaceuticals and Biologics

Posted 21 December 2012 | By Alexander Gaffney, RAC

Health Canada will be requesting Development Safety Update Reports (DSURs) from selected sponsors of clinical trials for pharmaceuticals, biologics and biotechnology products, vaccines, and blood products as part of a new pilot project, it has announced.

According to a 20 December 2012 notice, the pilot is intended to provide the agency with an opportunity to see how DSURs-used to inform regulators about evolving safety data-can be integrated into the review of Clinical Trial Applications (CTA), New Drug Submissions (NDS), and Supplemental New Drug Submissions (SNDS).

Health Canada adopted the International Conference on Harmonization (ICH) guidance E2F: Development Safety Update Report in June 2012.

The sponsors targeted by the pilot will be required to submit DSURs "as a stand-alone regulatory activity, separate from any other information." DSURs from all other sponsors will only be needed in the case of significant new safety information or other important changes to the safety profile of their investigational drug.

 

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