HC Plans Wider Use of Foreign Reviews in Device Licensing Process
Health Canada has published draft guidelines outlining plans to make broader use of medical product reviews conducted by foreign regulators in its own review processes in order to better meet performance targets and improve regulatory assessments.
The regulator plans a pilot phase for specific products—including new applications for Class III and IV medical devices—starting October 2011 and running until March 2013 in which Canadian reviews of medical devices, pharmaceuticals and other medical products will incorporate data from foreign reviews. Comments on the proposal will be accepted until March 31, 2013.
Within the medical device sector, HC’s proposal would affect Class III and IV Licence Applications as well as Class III and IV Licence Amendment Applications.
According to the HC guidelines, device reviews from the US FDA and European Medicines Agency are preferred, but HC may also consider foreign reviews from other regulator such as Swissmedic or the Therapeutic Goods Administration.
The new proposal does not alter submission requirements for Canadian market applicants, and HC will not grant market authorizations based solely on foreign reviews. In addition, applicants are not required to submit foreign reviews as part of their Canadian review processes.
HC lists four methods by which foreign reviews may be incorporated into Canadian reviews of devices:
- Canadian regulatory decisions based on critical assessments of foreign reviews
- Canadian reviews based on critical assessments of foreign reviews, referring to data filed in Canada as necessary; final regulatory decisions based on Canadian reviews
- Canadian reviews based on critical assessments of data filed in Canada, using foreign review data as added references
- Canadian regulatory decisions based on Canadian reviews because foreign review data is not relevant
For Class III and IV medical device applicants submitting foreign reviews along with their data packages, foreign reviews should be listed in data package tables of contents and included as appendices to data packages.