How is Canada collaborating internationally on vaccine regulatory issues?
As part of its regulatory preparedness activities, Health Canada actively participated in 2006-2007 in the development of WHO Guidelines on Regulatory Preparedness for Human Pandemic Influenza Vaccines. The guidelines promote convergence between National Regulatory Authorities on regulatory evaluations of the quality, safety, and efficacy of vaccines that would be used in a pandemic situation. Since the pandemic virus emerged in April 2009, Canada has been participating in regular WHO regulatory teleconferences, as well as collaborating with other national regulatory authorities, such as the United States Food and Drug Administration, the European Medicines Agency, and the Australian Therapeutic Goods Administration in regular discussions on clinical development and pharmacovigilance plans for H1N1 flu vaccines. There is a global commitment amongst regulators to share data in real time. Due to seasonal differences in the Northern and Southern hemispheres, countries in the Southern hemi
