PAT 201 COMPREHENSIVE TEST PAPER
2026 QUESTIONS AND CORRECT ANSWERS
GRADED A+
●● Canadian Drug Regulations
Answer: Created to protect public from drug misuse and provide
mechanism for quality assurance for safety & efficacy
●● Health Products and Food Branches (HPFB)
Answer: HPFB of Health Canada is responsible for ensuring safety and
quality of drugs, biologics, and natural health products
●● What is the standard set by?
Answer: Food and Drug Act and Regulations
●● How many steps are there for approval of drugs marketed in
Canada?
Answer: 8 steps
●● STEP 1
Answer: Initial drug research is conducted
, ●● STEP 2
Answer: Preclinical studies in cultured cells, living tissue, and species of
animals are performed
●● STEP 3
Answer: A Clinical Trial Application (CTA) is submitted to Health
Canada, followed by extensive clinical trials which are done in 4 phases
●● 4 Phases of Clinical Trials
Answer: Phase 1: Safety phase; a small group of healthy humans
Phase 2: Effectiveness phase; small group of humans with the target
disorder
Phase 3: Confirmation phase; larger groups of clients with the target
disorder
Phase 4: Monitoring phase; after drug is approved and in the market,
more info is gathered on use, benefits, and risks
●● STEP 4
Answer: The pharmaceutical company completes a New Drug
Submission (NDS) to Health Canada which details important safety and
2026 QUESTIONS AND CORRECT ANSWERS
GRADED A+
●● Canadian Drug Regulations
Answer: Created to protect public from drug misuse and provide
mechanism for quality assurance for safety & efficacy
●● Health Products and Food Branches (HPFB)
Answer: HPFB of Health Canada is responsible for ensuring safety and
quality of drugs, biologics, and natural health products
●● What is the standard set by?
Answer: Food and Drug Act and Regulations
●● How many steps are there for approval of drugs marketed in
Canada?
Answer: 8 steps
●● STEP 1
Answer: Initial drug research is conducted
, ●● STEP 2
Answer: Preclinical studies in cultured cells, living tissue, and species of
animals are performed
●● STEP 3
Answer: A Clinical Trial Application (CTA) is submitted to Health
Canada, followed by extensive clinical trials which are done in 4 phases
●● 4 Phases of Clinical Trials
Answer: Phase 1: Safety phase; a small group of healthy humans
Phase 2: Effectiveness phase; small group of humans with the target
disorder
Phase 3: Confirmation phase; larger groups of clients with the target
disorder
Phase 4: Monitoring phase; after drug is approved and in the market,
more info is gathered on use, benefits, and risks
●● STEP 4
Answer: The pharmaceutical company completes a New Drug
Submission (NDS) to Health Canada which details important safety and
