As previously reported, the Food and Drugs Act (the Act) has been substantively amended by Bill C-17, also known as Vanessa’s Law; the Bill received Royal Assent in 2014. According to the Federal Government, the amendments are intended to strengthen safety oversight of therapeutic products and improve reporting by health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products (the Act defines a therapeutic product as a drug or a device, or a combination of the two). Health Canada is now requesting feedback on two initiatives related to the amendments:
1. Drug Safety Information Survey: Health Canada is inviting stakeholders including the general public, patients, healthcare professionals and pharmaceutical companies to complete an online survey to assess their information needs regarding therapeutic products. According to Health Canada, the results of the survey will be used to improve the manner in which information about therapeutic products is disseminated, in support of Health Canada’s goal of providing Canadians with credible and timely information allowing them to make informed decisions concerning their health.
The survey will be open until May 25, 2015.
2. Guide to New Authorities Consultation: Health Canada is inviting stakeholders to comment on its Guide to New Authorities, intended to establish the principles, policies and standards to be followed in the exercise of the Minister’s new powers, including the power to order a recall of a therapeutic product, to disclose information of regulated entities (as previously reported here), and to order a label change or package modification.
Comments will be accepted until June 8, 2015.