Sponsors must conduct
all clinical trials in accordance with the principles of Good Clinical
Practice.
Approval for the conduct of a clinical trial must be obtained from
the national regulatory authority Therapeutic Products Directorate
(TPD), which is responsible for drugs and medical devices. For this
purpose, the sponsor must submit a Clinical Trial Application (CTA)
to Health Canada prior to initiation of the clinical trial (Phases
I to III and comparative bioavailability trials). The CTA will be
reviewed, and the sponsor will be notified within 30 days if the application
is deficient. For comparative bioavailability trials and Phase I trials
in healthy adult volunteers the targeted review time is 7 days.
Health Canada invites sponsors to request a pre-CTA consultation meeting,
which provides an opportunity for the sponsor to present relevant
information on the trial and for Health Canada to give guidance on
the acceptability of the proposed trial.
Sponsors are not required to file a CTA for Phase IV clinical trials.
 Health
Care System |
| Canada's health care
system is publicly funded and provides comprehensive health
care services for medically necessary inpatient and outpatient
care. The physicians, who operate as private practitioners,
receive compensation for their services from the government. |
|
CANADA
