Model competencies in regulatory therapeutic product assessment: Health Canada's good review guiding principles as a reviewing community's code of intellectual conduct.
OBJECTIVE
This article describes some work from the Therapeutic Products Directorate of Health Canada regarding Good Review Practices (GRP).


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.
Lim
Robyn R
RR
Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Ottawa, Ontario, Canada. Robyn_Lim@hc-sc.gc.ca
D002170:Canada; D032781:Codes of Ethics; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D007880:Legislation, Drug / Q000941:ethics / Q000458:organization & administration*; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D018570:Risk Assessment / Q000331:legislation & jurisprudence