regulatory approval
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how many days to access new medecines from from HC approval to access
approx 732 days -this is because there are different federal, provincial and territorial agencies
what does health canada govern
the safety, quality and labeling of foods and drugs in canada
The Food and Drug Regulations provide detailed requirements for various aspects related to foods and drugs:
o Manufacturing o Packaging o Labelling o Storage o Importation o Distribution o Sale o Clinical trials for drugs
what are the 2 main health canada’s roles
-responsible for enforcing these standards -regulatory mandate (regulatory review) under the food and drug regulations
usually how long does it take for a clinical trial to be approved
-phase 1: 7 days -rest of phases: 30 days
how long does nds review take
there are 3 reviews -priority: 180 days -NOC/c: 200 days -regular: 300 days
cost new active substance
590 346$
cost clinical or non clinical data and chemistry and manifacturing data
305 690$
cost of clinical or non clinical data only
122 232 $
cost of comparative studies
68 889$
canadians wait…. on average for access to new medecines
2 years aka 732 days
number of days from global first launch to public reimbursement in canada
1301 days new zealand is higher
how long does the drug establishment license (DEL) take to process take
250 days to process
the del is important for what
fabricate, package/label, test, import, distribute and wholesale
The PMPRB reviews the prices of what?
patented medicines sold in Canada to make sure prices are not “excessive”
what is the pmprb
patented medecine prices review board
PMPRB11 refers to…
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
true or false: the provincial government is responsible for funding health care services
true -this includes decisions related to which drugs will be funded based on the priorities, resources and budget unique to each province
Pan-Canadian Pharmaceutical Alliance is made up of what
-provincial, territorial and federal agencies tho federal is less important
how long does the private plan from approval to patient access
226 days
how long foes it take for a public plan from approval to patient access
732 days
true or false: less than 25% of new medecines are reimbursed by public plans in canada
false it is 20%
true or false: advertising of prescription drugs directly to the general public is…..
strictly prohibited in canada
advertising to consumer in canada is restricted to:
name of drug, price, and quantity and may not state or imply its therapeutic benefit