Pharmacy PEBC Practice Exam

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Question: 1 / 20

For a drug undergoing research and development processes in Canada, which of the following statements is correct?

Application for patent protection is granted for a maximum period of three years.

A New Drug Submission must be filed in order to start clinical trials.

Clinical trials involve three phases that assess animal safety and efficacy.

Health Canada, under the Food & Drugs Act & Regulations, provides Notice of Compliance

Health Canada provides Notice of Compliance under the Food and Drugs Act and Regulations, which means that the drug has met safety, efficacy, and quality standards and can be marketed in Canada. This option is correct, while the other options are incorrect due to the following reasons - Option A is incorrect, as a patent for a drug can be granted for a period of up to 20 years, not three years. - Option B is incorrect, as a New Drug Submission must be filed before marketing a new drug in Canada, not before starting clinical trials. - Option C is incorrect, as clinical trials generally have four phases (not three), and they involve testing the drug on humans, not animals. Animal testing is usually done in pre-clinical stages of drug development.

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