On November 30, 2007, Health Canada posted a notice to provide an update on Health Canada's initiative on the registration and disclosure of clinical trial information for products such as drugs and medical devices. The notice indicates that Health Canada is currently considering development of regulatory requirements for registration of clinical trials and disclosure of results. However, in the meantime Health Canada is encouraging sponsors to register their clinical trials within 21 days of the commencement of a clinical trial using one of the WHO's register networks: the ClinicalTrials.gov ( www.clinicaltrials.gov) or Current Controlled Trials International Standard Randomised Controlled Trials Number Register ( www.controlled-trials.com/isrctn).
Health Canada is considering the creation of a Canadian search portal for clinical trials. The notice indicates that since the initiative was launched, Health Canada has conducted extensive consultations and has received a strong consensus among stakeholders that a Canadian approach should be consistent with the international direction. Further, the notice states that if a decision is made to proceed with the regulatory requirements, there will be further opportunity for stakeholders to provide feedback on the issues such as timing of registration, the registration of early phase trials and disclosure of clinical trial results.
The full text of this notice can be found at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/proj/enreg-clininfo/notice_ctreg_avis_ecenr_e.html