626 - We have an ongoing pivotal study and would like to report the latest published data. While the data exceeds the duration of that mentioned in the TMA, it is directionally-consistent with respect to magnitude/significance, and no additional safety concerns were identified. Can we report this data in APS, if there is no emphasis placed on the duration?
Jennifer Carroll last edited by
No. PAAB review is based on the Health Canada approved terms of market authorization. Published studies must be consistent with and within the limitations of the TMA to be considered for inclusion in advertising. Consistency with the TMA is assessed based on a number of parameters, including the duration of the study. If an ongoing study goes beyond the duration of use within the TMA, this would be deemed to be outside of the limitations of the TMA. Copy indicating that Health Canada has reviewed and accepted the efficacy and safety of the product for the extended duration would be required prior to assessing the acceptability of the data in advertising. Please see response to question 585 as well: No. The data from the later analysis can only be included in the piece once it is included in the TMA