BPS 4102 EXAM QUESTIONS
WITH 100% CORRECT
ANSWERS
What is the purpose of CTO regulations? - Answer-It is to be applied to existing routine
medical practice where safety and effectiveness has already been established
What is the CTO criteria? - Answer-a criteria used to determine the effectiveness and
safety of a transplant
What pathway on the decision tree does a CTO need to take to be regulated? - Answer-
Allogeneic -> MM (yes) -> HU (yes) -> SE/MA (no) : CTO regulations
Does the CTO regulatory pathway require pre-market review? - Answer-no
Are CTPs regulated as biologics? - Answer-Yes
What are the two defining features of stem cells? - Answer-1. self-renewing
2. capable of differentiation
What are pluripotent stem cells? - Answer-highly potent stem cells that generally only
exist during early embryo stages
What is a New Drug Submission? - Answer-- Needed for a notice of compliance
- priority type: 180 days
- standard type: 300 days
What is a priority review new drug submission? - Answer-- submissions for drugs for
life-threatening diseases
Conditions for submission:
1. no existing treatment
2. smaller risk over existing treatments
What is screening? - Answer-Assessment done of a submission to determine if its
acceptable
What are the 3 parts of the Product monograph? - Answer-1. health professional
information
,2. scientific information
3. consumer information
What does the Health Professional Info contain? - Answer-- dosage and administration
- adverse reactions
- contraindications
- clinical use
What occurred in 1854? - Answer-Cholera Outbreak
What did the Cholera outbreak lead to? - Answer-- ad hoc patchwork health boards in
New Brunswick and Upper Canada
What is an Act? - Answer-A law that must be signed in by the royal assent
What is regulation? - Answer-Subordinate legislation, enforces the act
What 2 acts were implemented following the confederation of Canada? - Answer-1.
Quarantine Act
2. Sick Mariners Act
What is the Quarantine act? - Answer-Allowed federal officials to inspect arriving ships
for sick passengers
What is the sick mariners act? - Answer-Provided special medical services for seaman
that fell ill on canadian waters
What occured in 1919? - Answer-The establishment of the Department of Health in
Canada
What occured in 1928? - Answer-Department of Health Mandate expanded, renamed
pensions and national health
What was created in 1944? - Answer-Department of Veterans Affairs and Department of
National Health and Welfare
What was the department of National Health and Welfare responsible for ? (1944-1993)
- Answer-- Research public health issues
- promotion of health and social security
What was the Department of National Health and Welfare renamed to in 1993? -
Answer-Department of Health
TPD - Answer-Therapeutic products directorate
, BGTD - Answer-Biologics and genetic therapies directorate
MDD - Answer-Medical Devices Directorate
NNHPD - Answer-Non-prescription and natural health products directorate
VDD - Answer-Veterinary drugs directorate
What was amended in 1875? - Answer-Inland Revenue Act
What is the inland revenue act? - Answer-to Impose License Duties on Compounders of
Spirits and to amend the Act Respecting Inland Revenue to Prevent the Adulteration of
Food, Drink and Drugs
What were the four amendments made to the Inland Revenue Act (1875) - Answer-1)
Workable terminology: Drugs were defined as "all articles used for curative or medicinal
purposes"
2) Established standards through licensing
3) Proper labelling and advertisements by manufacturers
4) Sanctions to allow government to train inspectors
AA - 1884 - Answer-Adulteration Act
What is the adulteration act and its amendments? - Answer-Canada's response to ban
adulteration of food and drugs.
1. Adhere to the Inland Revenue Act
2. Improved manufacturing standards to better align with USA and Britian
3. Updated definitions
4. Separate regulations for food, drugs, and liquor
What happened in 1920? - Answer-The Adulteration Act was replaced with the Food
and Drugs act
How many amendments were made to the food and drugs act after 1950? - Answer-3
What were the 2 amendments made to the Food and Drugs act? - Answer-1. 1927 -
Revised the definition of drugs to better encompass everything
2. 1936 - Expanded the definition of drug to include cosmetics and articles used in the
diagnosis, treatment, mitigation or prevention of disease in man or animal
What occured in 1963? - Answer-Amendments were made to the Food and Drug
Regulations act following the thalidomide incident
What were the 6 changes made to the FDA / FDR? - Answer-1. Added section "H" :
restricted drugs
WITH 100% CORRECT
ANSWERS
What is the purpose of CTO regulations? - Answer-It is to be applied to existing routine
medical practice where safety and effectiveness has already been established
What is the CTO criteria? - Answer-a criteria used to determine the effectiveness and
safety of a transplant
What pathway on the decision tree does a CTO need to take to be regulated? - Answer-
Allogeneic -> MM (yes) -> HU (yes) -> SE/MA (no) : CTO regulations
Does the CTO regulatory pathway require pre-market review? - Answer-no
Are CTPs regulated as biologics? - Answer-Yes
What are the two defining features of stem cells? - Answer-1. self-renewing
2. capable of differentiation
What are pluripotent stem cells? - Answer-highly potent stem cells that generally only
exist during early embryo stages
What is a New Drug Submission? - Answer-- Needed for a notice of compliance
- priority type: 180 days
- standard type: 300 days
What is a priority review new drug submission? - Answer-- submissions for drugs for
life-threatening diseases
Conditions for submission:
1. no existing treatment
2. smaller risk over existing treatments
What is screening? - Answer-Assessment done of a submission to determine if its
acceptable
What are the 3 parts of the Product monograph? - Answer-1. health professional
information
,2. scientific information
3. consumer information
What does the Health Professional Info contain? - Answer-- dosage and administration
- adverse reactions
- contraindications
- clinical use
What occurred in 1854? - Answer-Cholera Outbreak
What did the Cholera outbreak lead to? - Answer-- ad hoc patchwork health boards in
New Brunswick and Upper Canada
What is an Act? - Answer-A law that must be signed in by the royal assent
What is regulation? - Answer-Subordinate legislation, enforces the act
What 2 acts were implemented following the confederation of Canada? - Answer-1.
Quarantine Act
2. Sick Mariners Act
What is the Quarantine act? - Answer-Allowed federal officials to inspect arriving ships
for sick passengers
What is the sick mariners act? - Answer-Provided special medical services for seaman
that fell ill on canadian waters
What occured in 1919? - Answer-The establishment of the Department of Health in
Canada
What occured in 1928? - Answer-Department of Health Mandate expanded, renamed
pensions and national health
What was created in 1944? - Answer-Department of Veterans Affairs and Department of
National Health and Welfare
What was the department of National Health and Welfare responsible for ? (1944-1993)
- Answer-- Research public health issues
- promotion of health and social security
What was the Department of National Health and Welfare renamed to in 1993? -
Answer-Department of Health
TPD - Answer-Therapeutic products directorate
, BGTD - Answer-Biologics and genetic therapies directorate
MDD - Answer-Medical Devices Directorate
NNHPD - Answer-Non-prescription and natural health products directorate
VDD - Answer-Veterinary drugs directorate
What was amended in 1875? - Answer-Inland Revenue Act
What is the inland revenue act? - Answer-to Impose License Duties on Compounders of
Spirits and to amend the Act Respecting Inland Revenue to Prevent the Adulteration of
Food, Drink and Drugs
What were the four amendments made to the Inland Revenue Act (1875) - Answer-1)
Workable terminology: Drugs were defined as "all articles used for curative or medicinal
purposes"
2) Established standards through licensing
3) Proper labelling and advertisements by manufacturers
4) Sanctions to allow government to train inspectors
AA - 1884 - Answer-Adulteration Act
What is the adulteration act and its amendments? - Answer-Canada's response to ban
adulteration of food and drugs.
1. Adhere to the Inland Revenue Act
2. Improved manufacturing standards to better align with USA and Britian
3. Updated definitions
4. Separate regulations for food, drugs, and liquor
What happened in 1920? - Answer-The Adulteration Act was replaced with the Food
and Drugs act
How many amendments were made to the food and drugs act after 1950? - Answer-3
What were the 2 amendments made to the Food and Drugs act? - Answer-1. 1927 -
Revised the definition of drugs to better encompass everything
2. 1936 - Expanded the definition of drug to include cosmetics and articles used in the
diagnosis, treatment, mitigation or prevention of disease in man or animal
What occured in 1963? - Answer-Amendments were made to the Food and Drug
Regulations act following the thalidomide incident
What were the 6 changes made to the FDA / FDR? - Answer-1. Added section "H" :
restricted drugs
