pharmacogenomics regulation, pharmacogenetics regulation
In the first part of our analysis, we will examine the impact which pharmacogenomics is expected to have on drug research and development, on the drug approval process and on post-marketing surveillance and clinical practice. This will allow us to show how pharmacogenomic testing could be beneficial to drug companies, regulatory bodies, and patients. The second part of our analysis will focus on the regulatory framework applicable to the approval of pharmacoge- nomic tests in Canada, although we are aware of the fact that most manufacturers decide to approve their tests outside of Canada. As mentioned, the applicable regu- lations will depend on the way the test is marketed; the federal and provincial re- quirements will both be covered in detail. It is interesting to note that very few pharmacogenomic test developers currently choose to get their tests approved by Health Canada. Most often they will commercialize their product in the United States first and go through the provincial approval route when seeking approbation in Canada.7
The review of the expected benefits and of the Canadian regulatory framework governing pharmacogenomic tests will then allow us to evaluate if the latter is ap- propriate considering the positive impact pharmacogenomics could have on phar- maceutical development and the health care system. We will discuss the question of whether it should be changed and simplified so that manufacturers could obtain faster (or simplified) approval for their tests in order to commercialize them more rapidly.
Yann Joly and Emma Ramos-Paque, "Approval of New Pharmacogenomic Tests: Is the Canadian Regulatory Process Adequate?" (2010) 8:2 CJLT.