The idea of creating the Canadian Alliance for Safe and Effective Medications in Pregnancy and Breastfeeding (CaseMed-Pregnancy) emerged following the Motherisk Symposium Establishing a New Benchmark for Drug Evaluation during Pregnancy, which took place during the 2006 Canadian Therapeutics Congress. The objective of this symposium was to review and discuss scientific and regulatory issues, challenges and solutions to ensure that pregnant women in need of drug therapies can be safely treated.

At the conclusion of this meeting, it was recommended that Health Canada develop a new drug review strategy and create a scientific advisory board of experts responsible for providing advice and recommending guidelines on drug therapy in pregnancy and breastfeeding. This advisory board would include participation from government, professional medical organizations, industry and representatives of the public.  It would play a critical role in ensuring that any drug to be labelled for use during pregnancy undergo rigorous scientific and regulatory standards of safety and efficacy. The collection and analysis of data on foetal safety should be a key part of any drug review standard and/or guidelines aimed at safeguarding the health of pregnant women and their offspring. An on-going post-marketing surveillance system should also be established in partnership with all concerned stakeholders.