Healthy Skepticism Library item: 12757

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Lim RR.
Model competencies in regulatory therapeutic product assessment: Health Canada's good review guiding principles as a reviewing community's code of intellectual conduct.
Pharmacoepidemiol Drug Saf 2007 Aug; 16:(8):933-41
http://www3.interscience.wiley.com/cgi-bin/abstract/114114627/ABSTRACT?CRETRY=1&SRETRY=0

Abstract:

PURPOSE: This article describes some work from the Therapeutic Products Directorate of Health Canada regarding Good Review Practices (GRP). METHODS AND RESULTS: Background information is provided on the Therapeutic Products Directorate (TPD) and its regulatory activities regarding drug and medical device assessment in both the pre- and post-market setting. The TPD Good Review Guiding Principles (GRGP) are described which include a Definition of a Good Therapeutic Product Regulatory Review, Ten Hallmarks of a Good Therapeutic Product Regulatory Review and Ten Precepts. Analysis of the guiding principles discusses possible linkages between the guiding principles and intellectual virtues. CONCLUSIONS: Through this analysis an hypothesis is developed that the guiding principles outline a code of intellectual conduct for Health Canada’s reviewers of evidence for efficacy, safety, manufacturing quality and benefit-risk regarding therapeutic products. Opportunities to advance therapeutic product regulatory review as a scientific discipline in its own right and to acknowledge that these reviewers constitute a specific community of practice are discussed. Integration of intellectual and ethical approaches across therapeutic product review sectors is also suggested.

Keywords:
Canada Codes of Ethics Drug Approval/legislation & jurisprudence* Drug Industry/legislation & jurisprudence* Drug Industry/standards Humans Legislation, Drug/ethics Legislation, Drug/organization & administration* Product Surveillance, Postmarketing Quality Control Risk Assessment/legislation & jurisprudence