HEALTH CANADA REGULATION
What does NOC stand for?
Notice of Compliance
Purpose of a Master File (MF)?
What is post-market surveillance?
Monitoring drug safety after approval
Hc actions for risky drugs?
Label changes, recalls and withdrawals
Number of Master Files Types?
5
Time hospital have to report ADR?
30 DAYS
What is NOC/c?
Approval with post market conditions
What is an ADR signal?
Potential safety issues from reports
Average drug review time in Canada?
6 months to 2 years
Role of Letter of Access (LoA)?
Allows HC to access MF information
What is HC vigilance?
Post market drug safety monitoring
what is an expedited review?
faster review for urgent needs
Why strict vaccine monitoring?
public trust and safety
Primary reason for regulatory delays in Canada?
Market Size & Later Submissions
Different Active Substance, synthesis or form
Serious adverse reaction percentage?
above 70%
Priority-reviewed drugs safety warning rate?
above 30%
How does HC communicate risks?
risk communication, recalls, black box warnings
What factors affect HC approval timelines?
strict policies, regulations and data access
Who submits an MF?
Manufacturer or authorized agent
ADR reports, foreign data, literature etc.
What is the impact delayed approvals?
What are examples of serious ADRs?