Canada taps into US online gateway for faster drug submissions
This article was originally published in SRA
Health Canada has started using a dedicated channel of the US Food and Administration's electronic submissions gateway (ESG) which for the first time allows pharmaceutical companies to submit drug authorization data online to the Canadian regulator1,2.
The common electronic submissions gateway (CESG) not only makes it faster and easier for companies to submit their data to Health Canada, it also accepts submissions from both Canada and the US and subsequently send those submissions to one or both regulatory authorities for independent review and approval. This latter feature is designed to make it more efficient for industry to submit applications for drug approvals to both countries.
The CESG's launch in Canada was announced on 31 January. It is the result of work by the Canada-US Regulatory Cooperation Council to better align the regulatory systems between both countries. The CESG is a modified version of the ESG that the FDA has been using since 2006. Prior to its launch in Canada, drug authorization packages have been sent to Health Canada via courier – either in hard copy format or on CD/DVD storage devices.
Health Canada has published links on its website on how to register, connect and submit regulatory transactions using the CESG3. Also on the website is a "frequently asked questions" document that, among other things, lists the regulatory transactions that can currently be sent to Health Canada via the CESG4. At the moment, Health Canada is only accepting the following regulatory transaction types via CESG:
- response to a clarification request;
- periodic safety update report (PSUR) requested during the pre-market review process by Canada's Therapeutic Products Directorate and Biologics and Genetic Therapies Directorate;
- comments to the summary basis of decision;
- pristine product monograph;
- second language product monograph; and
- drug notification form (DNF).
Companies that wish to submit a regulatory transaction that does not appear on this list are advised to use an alternate method of submission. Health Canada says it will be expanding the list to include additional regulatory transactions in the future.
Commenting on the CESG collaboration, the FDA's Robert Yetter said the gateway "has the potential to yield long-term positive outcomes for both FDA and Health Canada". Dr Yetter, who is associate director for review management at the agency's Center for Biologics Evaluation and Research, added: "The collaboration continues the work between the two regulatory partners to streamline both agencies’ submission requirements while maintaining consistency in regulatory requirements. It could also lead to cost reductions for regulated industry, which would not have to follow separate technical requirements for submission to the two countries."
References
- Health Canada press release, 31 January 2014, www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2014/2014-012-eng.php
- FDAVoice blog, 31 January 2014, http://blogs.fda.gov/fdavoice/index.php/2014/01/
- Health Canada, Common Electronic Submissions Gateway, website accessed 14 February 2014, www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/cesg-pcde/index-eng.php
- Health Canada, Frequently asked Questions, website accessed 14 February 2014, www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/cesg-pcde/faq-eng.php