Canadian Drug Regulatory Framework

Abstract

• An application to Health Canada (HC) to market a new drug in Canada is done by the sponsoring pharmaceutical company; the application typically includes animal data, chemistry and manufacturing data, and the results from clinical trials of various phases. The amount of data submitted in support of a new chemical entity frequently reaches hundreds of volumes.• The role of drug evaluators is to critically assess both the data and the sponsor's interpretation of the data in order to determine, on a population basis, the potential benefits and the potential harms (i.e., risks) associated with taking the drug. Evaluators apply regulatory expertise to reach an evidence-and contextbased recommendation as to the risk-benefit profile of the drug within the context of the proposed conditions of use. ABSTRACT:The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what "authorization to market a drug in Canada" means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to the drug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues. RÉSUMÉ: Cadre de réglementation canadien sur les médicaments. Au Canada, le rôle de ceux qui évaluent les soumissions à l'organisme de réglementation est critique, tant en ce qui concerne l'évaluation des données soumises que leur interprétation par le promoteur afin d'arriver à une recommandation basée sur les données et sur le contexte quant aux bénéfices et aux dangers (c.-à-d. aux risques) potentiels associés à la prise du médicament, tels que décrits dans la soumission. Le but de ce document est de faire une esquisse du cadre réglementaire régissant cette évalua...

Pathogen inactivation: an American view

“…Regulatory agencies approve technologies based on their safety and efficacy. In Canada and in many other countries, a distinction exists between regulatory authorization to market a drug and common practice [40]. Widespread implementation of novel technologies such as PI will have a number of implications for blood services (and beyond).…”

Pathogen inactivation: making decisions about new technologies

“…Regulatory agencies approve technologies based on their safety and efficacy. In Canada, and in many other countries, a distinction exists between regulatory authorization to market a drug and common practice 58 . Widespread implementation of novel technologies such as PI will have a number of implications for blood services (and beyond).…”

“…The manufacturer, the supplier, and provincial departments or ministries of health have the responsibility to ensure that this information is conveyed to physicians and health‐care providers in a timely and effective manner. Finally, cost‐effectiveness studies should be conducted by agencies such as the Canadian Agency for Drugs and Technologies in Health 58 …”

“…In Canada, and in many other countries, a distinction exists between regulatory authorization to market a drug and common practice. 58 Widespread implementation of novel technologies such as PI will have a number of implications for blood services (and beyond). Several technologies are already approved for fresh-frozen plasma treatment in some countries, and it is possible, even likely, that more than one technology will be approved for each of the labile blood components.…”

“…Finally, cost-effectiveness studies should be conducted by agencies such as the Canadian Agency for Drugs and Technologies in Health. 58…”