Canada’s regulatory regime needs to adapt to these vast changes to healthcare. Modernizing regulatory practices will ensure Canada provides Canadians with the best of what health discovery and research offers.
Access To Innovative Therapies
Innovative biotechnology companies developing advanced therapies face challenges in getting their products to Canadian patients. Restricted market access and slow adoption of new technologies has serious implications for Canadians. BIOTECanada is working with Federal Provincial and Territorial review bodies such as the Common Drug Review (CDR) to create a better environment for the adoption of breakthrough therapies and greater recognition of the value of innovation.
Establishing a Canadian Orphan Product Policy
Canadians who live with orphan diseases deserve the same access to life-saving interventions as in other countries. BIOTECanada is working with all levels of government and key partners to establish a forward-looking Orphan Product Policy with the necessary legislative and regulatory parameters to ensure Canadians can get the therapies they need, and that companies have an incentive to develop and introduce products for orphan diseases. Read more.
Subsequent Entry BiologicS (SEBS)
The term Subsequent Entry Biologic (SEB) is used by Health Canada to describe “a biologic product that is similar to and would enter the market subsequent to an approved innovator biologic product.” The agency is currently considering the regulatory process by which such products would be granted a marketing licence in Canada.
BIOTECanada supports the creation of a regulatory pathway for the regulation of SEBs that incorporates processes and requirements that protect the safety of patients.
BIOTECanada members have developed a set of principles that the biotechnology industry believes should guide the introduction and regulation of SEBs in the Canadian marketplace.