Drug regulation Flashcards
WHO, six building blocks
Service delivery health workforce health information systems medical products vaccines and technologies healthcare financing leadership and governance (stewardship)
Turning point of heroic medicine because of:
scientific thinking, clinical trials and government regulation
it had to be safe and effective!
What does the Declaration of Helsinki provide?
Ethical framework, principles by the World Medical Association, funded in ‘64, major revision in 2000, protects participant of a study.
What kind of trial regulations are there?
local regulatory requirements ( CH - Swissmedic)
Declaration of Helsinki
ICH: nternational Conference on Harmonisation of Technical Requirements for registration of pharmaceuticals for human use.
The health authority does not test drugs itself, what does it?
provides methodological research on drug quality, safety and effectiveness standards. (FDA)
Regulatory body:
issues new regulations issues guidance documents product review and product approval inspection and enforcement consumer information
What does Swissmedic control?
medicinal products.
What does the Federal Office of Public Health control?
nutritional products and cosmetics
Swissmedic is nontransparent:
does not communicate negative decisions
no exchange of data with FOPH
no exchange of data with EMA
What is EMA? and what does it?
European Medicines Agency, funded in 95. Harmonizes the work of national authorities together.
technical guidelines and scientific advice
Centralized pharmacovigilance systems
Tell us what pharmaceutical entities are:
drugs (chemical) biological products (viruses, vaccines) medical devices (apparatus, implants) combination products (emla patch)
Difference between medical devices and drugs
Drugs are tested in humans, devices are only tested for functioning. Drugs take a long time to get out there and are therefore not changed easily. Devices have lots of updates or new versions - cost more…
