Health Canada Finds Tenth of Clinical Trials Are Out of Compliance

Roughly 8 percent of clinical trials inspected by Health Canada between 2004 and 2011 failed to comply with agency regulations, according to a new report. In all, Health Canada’s Health Products and Food Branch Inspectorate observed 3,148 instances of noncompliance during 329 clinical trial inspections and 31 research ethics board (REB) assessments over the period. Of those, 54 percent were considered to be minor, 39 percent major and 1 percent critical. The remaining 6 percent were observations made during REB assessments.
International Pharmaceutical Regulatory Monitor