regulatory approval

Question 1

how many days to access new medecines from from HC approval to access

Answer 1

approx 732 days
-this is because there are different federal, provincial and territorial agencies

Question 2

what does health canada govern

Answer 2

the safety, quality and labeling of foods and drugs in canada

Question 3

The Food and Drug Regulations provide detailed requirements for various aspects related to foods and drugs:

Answer 3

o Manufacturing
o Packaging
o Labelling
o Storage
o Importation
o Distribution
o Sale
o Clinical trials for drugs

Question 4

what are the 2 main health canada’s roles

Answer 4

-responsible for enforcing these standards
-regulatory mandate (regulatory review) under the food and drug regulations

Question 5

usually how long does it take for a clinical trial to be approved

Answer 5

-phase 1: 7 days
-rest of phases: 30 days

Question 6

how long does nds review take

Answer 6

there are 3 reviews
-priority: 180 days
-NOC/c: 200 days
-regular: 300 days

Question 7

cost new active substance

Answer 7

590 346$

Question 8

cost clinical or non clinical data and chemistry and manifacturing data

Answer 8

305 690$

Question 9

cost of clinical or non clinical data only

Answer 9

122 232 $

Question 10

cost of comparative studies

Answer 10

68 889$

Question 11

canadians wait…. on average for access to new medecines

Answer 11

2 years aka 732 days

Question 12

number of days from global first launch to public reimbursement in canada

Answer 12

1301 days
new zealand is higher

Question 13

how long does the drug establishment license (DEL) take to process take

Answer 13

250 days to process

Question 14

the del is important for what

Answer 14

fabricate, package/label, test, import, distribute and wholesale

Question 15

The PMPRB reviews the prices of what?

Answer 15

patented medicines sold in Canada to make sure prices are not “excessive”

Question 16

what is the pmprb

Answer 16

patented medecine prices review board

Question 17

PMPRB11 refers to…

Answer 17

the 11 countries used as a
reference to determine the maximum price that can be charged in Canada:
Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway,
Spain, Sweden, UK

Question 18

true or false: the provincial government is responsible for funding health care services

Answer 18

true
-this includes decisions related to which drugs will be funded based on the priorities, resources and budget unique to each province

Question 19

Pan-Canadian
Pharmaceutical Alliance is made up of what

Answer 19

-provincial, territorial and federal agencies tho federal is less important

Question 20

how long does the private plan from approval to patient access

Answer 20

226 days

Question 21

how long foes it take for a public plan from approval to patient access

Answer 21

732 days

Question 22

true or false: less than 25% of new medecines are reimbursed by public plans in canada

Answer 22

false it is 20%

Question 23

true or false: advertising of prescription drugs directly to the general public is…..

Answer 23

strictly prohibited in canada

Question 24

advertising to consumer in canada is restricted to:

Answer 24

name of drug, price, and quantity and may not state or imply its therapeutic benefit

Question 25

if advertising legislative and regulatory provisions apply, one needs to first determine whether a....

Answer 25

particular message or activity is promotional or non promotional

Question 26

Since advertising is for the purpose of promoting the sale of a health product, it is critical to determine whether....

Answer 26

the purpose of a message is to promote the sale of a health product or to provide information

Question 27

The Pharmaceutical Advertising Advisory Board (PAAB) is an ...

Answer 27

independent and not-for-profit organization funded on a fee-forservice basis

Question 28

Preclearance service is recognized by Health Canada for.....

Answer 28

advertising directed to healthcare professionals

Question 29

the paab ensures what?

Answer 29

Ensures that healthcare product advertising meets the regulatory, scientific, therapeutic, and ethical standards outlined in the Code of Advertising Acceptance

Question 30

what is the imc

Answer 30

IMC is a national association of research-based pharmaceutical companies

Question 31

the imc code of ethical practices set out what

Answer 31

Standards and ethical requirements for the activities of all Member employees relating to the commercialization of Prescription Medicines to ensure that Members’ interactions with Stakeholders are appropriate and perceived as such.

Question 32

what is the asc

Answer 32

advertising standards of canada

Question 33

what is the casl

Answer 33

canada's anti spam legislation -federal law that aims to protect consumers and businesses from the misuse of digital technology

Question 34

what is the privacy act

Answer 34

federal legislation that protects the personal information of Canadians in the hands of the federal government. It is a key piece of Canada’s overall framework for protecting your privacy interests.

Question 35

what is the pipeda

Answer 35

private sector organizations, the Personal Information Protection and Electronic Documents Act (PIPEDA) sets out the ground rules for how organizations involved in a commercial activity can collect, use or share personal information.

Question 36

third generation daas have a ... effectiveness in curing hepc

Answer 36

98%

Question 37

average lifetime treatment cost for patients with hep c is...

Answer 37

79 656$

Question 38

what is the new canada drug agency

Answer 38

cad created in 18 dec 2023

Question 39

the cda will provide what

Answer 39

the dedicated leadership and coordination needed to make Canada's drug system more sustainable and better prepared for the future, helping Canadians achieve better health outcomes

Question 40

the cda will incorporate and...

Answer 40

expand on cadth expertise in the pharmaceutical sector including its strong leadership and technical proficiency

Question 41

The CDA will build on CADTH's existing mandate (health technology assessment, postmarket safety and effectiveness) and expand them to include:

Answer 41

* Improving the appropriate prescribing and use of medications; * Increasing pan-Canadian data collection and expanding access to drug and treatment data, including real-world evidence data; * Reducing drug system duplication and lack of coordination that causes expensive inefficiencies and pressures.