Year: 2010
Type: dissertation
Abstract: This thesis assesses the current status of Canadian prescription drug regulation and the policy drivers that guide this process. This analysis is accomplished by first providing a general survey of the steps, law, and institutional players involved in the full life-cycle of a drug. Next the evolution of current clinical trials and the gaps that the present legal regime creates in the scientific standards employed in clinical research is reviewed. This is followed by a discussion of how commercialization (innovation) and speed of approval (market access) are slowly becoming the dominant policy drivers for the Canadian regime. Finally a discussion of the proposed Progressive Licensing model, and Bill C-51-An Act to Amend the Food and Drug Act, raises the concerns with a shift to a system largely based on risk assessment and post-market monitoring (pharmacovigilence).
Source: eYLS (Yale Law School)
Author: Michael Duncan Taylor
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W2161759204