June 26, 2018
Health Canada, CADTH and INESSS are providing the option for aligned reviews for all biological and pharmaceutical new drug submissions. Effective immediately, a formalized aligned review process is available to drug manufacturers for new drugs and drugs for new indications. Health Canada is encouraging manufacturers to opt into this review process to help provide more timely access to drugs for all Canadians.
The early CADTH/ INESSS submissions, 180 days prior to NOC, was implemented to allow for timely information-sharing and to avoid duplication among all three agencies. As well, the 2017 pilot project in oncology, to align the review processes, resulted in learnings for this alignment.
What this means is for a standard HC submission (target of 300 calendar days), submissions to HTAs should be filed as early as 4 months into HC’s review. For NOC/c (target of 200 calendar days), submissions to HTA could be filed 3 weeks after submissions are accepted by HC. Finally, for priority reviews (target 180 calendar days), submissions to HTA’s and HC can occur at the same time.
Manufacturers interested in this opportunity must submit to Health Canada a completed “template authorizing share of information” and notify CADTH/ INESSS of their permission to HC for sharing information and documents. This process does not change the HTA’s submission requirements. As noted under Health Canada’s Principles of alignment, there are limits to the sharing of confidential information: “although the sponsor authorizes sharing of information, HC and HTAs will make best efforts to limit the sharing of information to those they deem relevant to the alignment of their reviews. For example, manufacturing process information would generally not be shared as it is typically not needed by the HTAs. In addition, Health Canada will respect existing Memoranda of Understanding (MOUs) with foreign regulators as it pertains to further sharing of information.”
For more information, please contact Marla Weingarten at email@example.com, Consultant, The Pangaea Group.