Drug Discovery, Development, Regulation Flashcards
Who discovered the xray, and when?
Wilhelm Rontgen 1895.
Who discovered penicillin and when?
Alexander Fleming, 1928
Who founded the field of genetics, and when?
Gregor Mendel, 1866
Who discovered germs and when?
Leewenhoak, 1676.
Who discovered the smallpox vaccination, and when?
Edward Jenner, 1796
Which body is responsible for drugs and medical device regulation?
Therapeutic Products Directorate, Health Products and Food Branch (HPFB), Health Canada
What information must be included in a New Drug Submission?
preclinical study results, clinical study results, production details, packaging/labelling processes, therapeutic value, conditions for use, adverse effects
What’s a supplemental NDS for?
Additions or changes to a product already on market (e.g. labelling, indication, manufacturing changes)
What does the manufacturer need from Health Canada before marketing?
Notice of Compliance and
Drug Identification Number
Which exceptions don’t need DINs?
radiopharmaceuticals, blood, blood products
Which branch are NHP regulated under?
Natural Health Products Branch
How are patented medicines’ prices regulated in Canada?
the Patented Medicine Prices Review Board (PMPRB) sets the factory-gate price
What time constraints does the Patent Act keep?
17 years of protection from patent issue date or 20 years from the filing date.
How do practitioners obtain drugs unavailable in Canada?
“Special Access Program” (SAP). Obtain on compassionate or emergency basis.
