regulatory approval Flashcards
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
if advertising legislative and regulatory provisions apply,
one needs to first determine whether a….
particular message or activity is promotional or non promotional
Since advertising is for the purpose of promoting the sale of a health product, it is critical to determine whether….
the purpose of a message is to promote the sale of a health product or to provide information
The Pharmaceutical Advertising Advisory Board (PAAB) is an …
independent and not-for-profit organization funded on a fee-forservice basis
Preclearance service is recognized by Health Canada for…..
advertising directed to healthcare professionals
the paab ensures what?
Ensures that healthcare product advertising meets the regulatory, scientific, therapeutic, and ethical standards outlined in the Code of Advertising Acceptance
what is the imc
IMC is a national association of research-based pharmaceutical companies
the imc code of ethical practices set out what
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.
what is the asc
advertising standards of canada
what is the casl
canada’s anti spam legislation
-federal law that aims to protect consumers and businesses from the misuse of digital technology
what is the privacy act
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.
what is the pipeda
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.
third generation daas have a … effectiveness in curing hepc
98%
average lifetime treatment cost for patients with hep c is…
79 656$
what is the new canada drug agency
cad created in 18 dec 2023
the cda will provide what
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
the cda will incorporate and…
expand on cadth expertise in the pharmaceutical sector including its strong leadership and technical proficiency
The CDA will build on CADTH’s existing mandate (health technology assessment, postmarket safety and effectiveness) and expand them to include:
- 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.
