In October 2011, Health Canada implemented a pilot project for the use of foreign review assessment information when evaluating health products seeking market authorization in Canada. While the use of foreign reviews is not new, Health Canada is seeking to formalize the practice in areas that already use foreign reviews, extend the practice to areas that currently do not, and standardize the practice across the Health Products and Food Branch. In furtherance of the project, Health Canada recently released a draft Guidance document that is intended to inform industry of the procedures to follow when including a foreign review in data packages and to detail changes to the project that Health Canada will be introducing based on internal and external comments and suggestions.
The scope of the project has been revised so that it now applies to New Drug Submissions (including abbreviated and supplemental), Drug Identification Number applications, Class III and IV Medical Device Licence applications and amendments, Periodic Safety Update Reports, Risk Management Plans and Notifiable Changes. Canadian data packages are still required to contain all of the modules and materials currently requested by Health Canada; however, foreign reviews may now be joined to specific components within the corresponding data package. The integrated applications are expected to facilitate Health Canada's use of foreign data to guide its own risk-benefit analysis in evaluating products.
Health Canada will consider data from foreign regulatory agencies which are similar to itself, such as the US Food and Drug Administration and the European Medicines Agency. The use of data from other foreign agencies will depend, in part, on the degree of similarity between the foreign and Canadian regulatory frameworks. As foreign data is meant to be complementary, when considering reviews prepared by foreign agencies, Health Canada has the discretion to vary the extent to which it references the data. The approach can range from basing the Canadian regulatory decision on a critical assessment of a foreign review to not referencing the foreign data at all. While the same approach may be used for review of the entire data package, different approaches may also be used for different components within the same data package.
Interestingly, while companies are not required to file a foreign review (nor can Health Canada unilaterally decide to delay the Canadian review until a foreign review is available), the draft Guidance provides that Health Canada may request a review directly from the foreign regulator if it is not available from the company. Importantly, as with other information filed in data packages, foreign reviews will be subject to the same protection regarding confidential business information and Access to Information requests.
Overall, the draft Guidance attempts to provide a framework for more consistent use of foreign reviews in the regulatory review process of health products in Canada. Interested stakeholders are advised that comments may be submitted until March 31, 2013. The draft Guidance document is not expected to be finalized until fiscal year 2013-2014.