Index
| Author | T. Nessim Abu-Zahra/Simon Carvalho/David Edwards |
| Pages | 325-340 |
-benzylpiperazine (“BZP”),
Abbreviated new drug submissions
(ANDS). See also Comparative sub-
missions; Extraordinary use new drug
submissions (EUNDs); New drug
submissions (NDS); Supplementary
new drug submissions (SNDS)
about, , –, –
approvals pathway, –
bioavailability studies, –
bioequivalence requirements, –, ,
–, –
brand-name vs generic drugs, –
Canadian reference product, , –,
–
content evidence requirements, –
declaration of equivalence, , –
disputes and reconsiderations, –
drug identication number application,
examination process, –
ling conditions, –
label mock-ups,
pharmaceutical equivalence requirements,
–
screening process, –
supplementary submissions, –
Acquired immune deciency syndrome
(AIDS), , , n
Advanced therapeutic products
(ATPs), n
Adverse drug reactions (ADRs), –, –
Advertising Standards Council (ASC), –
Agreement on Trade-Related Aspects of Intel-
lectual Property Rights (TRIPS), ,
, –, , –,
Alkyl nitrites,
Allogeneic blood, n
Alternative sales pathways
about, –
clinical trials, –
extraordinary uses, –
public health or military emergencies,
–
special access programme, –
urgent public health need, –
Andre, Harvie, –
Arthritis drugs, n
Assisted Human Reproduction Act (AHRA),
–, n, n
Index
T after a page number indicates a table.
The Regulation of Drugs in Canada
Bioavailability studies, –, ,
Bioequivalence
about,
comparative bioavailability studies,
–, ,
determination, –
pharmaceutical equivalence, –, ,
requirements, –, –
Biologic and Radiopharmaceutical Drugs
Directorate,
Biologic drugs
about,
good manufacturing practices,
lot release schedule,
on-site evaluations, n
segregation,
starting materials, –
testing protocols and samples,
Biosimilar drugs. See also Generic drugs
about,
comparative submissions, –, –,
examples of,
generic drugs, vs, –,
notice of compliance issuance reviews,
–
reference biologic drug, –
submission requirements,
Blais, Pierre,
Blood and blood components, –
blood coagulation product,
safety inquiry, –
tainted,
Blood Regulations, , , n, ,
Brand-name drugs
drug benet plans and formulary listing,
–
generic drugs, vs,
interchangeability, ,
new drug submissions, –,
patent validity litigation,
private vs public market, ,
Product Listing Agreements,
terminology,
Budget Implementation Act, , , , ,
n, n
Canada Border Services Agency (CBSA),
Canada Vigilance Adverse Reaction Online
Database,
Canada-European Union Comprehensive
Economic and Trade Agreement (CETA)
about,
basic patent denition,
certicates of supplementary protection,
, –
data protection,
domestic implementation, –
new chemical entities,
obligations, , –,
patent linkage,
pharmaceutical product denition,
sui generis protection, , –, ,
n, n,
Canada-European Union Comprehensive
Economic and Trade Agreement
Implementation Act, , , ,
–,
Canada’s access to medicines regime
(CAMR), ,
Canada-United States-Mexico Agreement
(CUSMA), , –, , n
Canadian Blood Services,
Canadian Intellectual Property Oce
(CIPO), n
Canadian Nuclear Safety Commission,
Canadian Pharmaceutical Alliance,
Canadian Red Cross, ,
Canadian reference product (CRP)
abbreviated new drug submissions,
–
about,
bioavailability studies,
bioequivalence, –
conditions of use, –
declaration of equivalence, , –,
,
generic drugs, , –
innovator surrogate drug, –
pharmaceutical equivalence, , –
Canadian Standards Association (CSA),
,
Cannabis Act and Regulations, , n
To continue reading
Request your trial