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Health Canada proposes new regulatory regime for drugs.

Authors :
Kondro, Wayne
Source :
Canadian Medical Association Journal (CMAJ); 4/24/2007, Vol. 176 Issue 9, p1261-1262, 2p, 1 Color Photograph
Publication Year :
2007

Abstract

The article reports that Health Canada is proposing a new regulatory regime for pharmaceuticals and biologics. The proposition was to support its move to lower the threshold for initial market authorization licenses in exchange for additional safety and efficacy studies as the condition for selling drug. The regulatory regime incorporates the notion of post-market surveillance into Health Canada. Nevertheless, the changes that the proposed regime offers are still being reviewed.

Subjects

Subjects :
REGIME change
BIOLOGICALS
DRUG laws

Details

Language :
English
Volume :
176
Issue :
9
Database :
Complementary Index
Journal :
Canadian Medical Association Journal (CMAJ)
Publication Type :
Academic Journal
Accession number :
25007855
Full Text :
https://doi.org/10.1503/cmaj.070449