Question

when there is a discrepancy between health canada's food and drug regulations, part c, division 5 and ich e6 gcp guidelines, which should be followed?

Answer 1

In case of discrepancy between Health Canada's Food and Drug Regulations and the ICH E6 GCP Guidelines, consider the context and jurisdiction. Follow both regulations if conducting clinical trials in Canada.

Step-by-step explanation:

In the case of a discrepancy between Health Canada's Food and Drug Regulations, Part C, Division 5, and the ICH E6 Good Clinical Practice (GCP) Guidelines, it is important to consider the context and jurisdiction in which you are operating.

Health Canada's regulations pertain to the Canadian context and are enforced within the country, while the ICH E6 GCP Guidelines are internationally recognized standards for clinical trials.

If you are conducting clinical trials in Canada, it is advisable to follow both regulations, ensuring compliance with Health Canada's specific requirements while also adhering to the internationally recognized standards outlined in the ICH E6 GCP Guidelines.