Other Ways in Which a Drug May Be Sold: Clinical Trials, Special Access, Extraordinary Use, Urgent Public Health Need, and Shortages

AuthorT. Nessim Abu-Zahra/Simon Carvalho/David Edwards
Other Ways in Which a Drug May Be
Sold: Clinical Trials, Special Access,
Extraordinary Use, Urgent Public
Health Need, and Shortages
Most drugs are made generally available for sale by way of the drug iden-
tication number (DIN) and notice of compliance (NOC) issuance path-
ways described in Chapter , or under Part  of the Natural Health Products
Regulations (NHPRs) (see Chapter ). ese types of market authorization
permit the marketing of a product. However, there are several other author-
ization pathways that may permit the lawful sale of a drug for more limited
purposes under the Food and Drugs Act (FDA). ese alternative pathways
serve a number of dierent public health and safety objectives, including to
permit the study of drugs in humans (the clinical trials regime) and enable
the sale of drugs in emergency circumstances (the Special Access, Urgent
Public Health Need, Extraordinary Use and Shortages regulations). As dis-
cussed below, in some cases these schemes are part of the DIN/NOC regimes,
and in other cases they are distinct from it.
is chapter will explain the following:
the regulation of drugs sold for the purpose of clinical trials under
Division  of the Food and Drug Regulations (FDRs)
 SOR/-.
RSC , c F-.
 SOR/-.
The Regulation of Drugs in Canada
the rules in Division  of the FDRs regarding special access to
unapproved new drugs for emergency treatment of a patient
the rules in Division  of the FDRs for drugs for urgent public health
need or for exceptional import in response to a shortage
the rules in Division  of the FDRs providing for special access to
an unapproved drug for public health or military health emergencies
A clinical trial is dened in section  of the FDA as a study involving human
subjects for the purpose of discovering or verifying the eects of a drug,
medical device, or food for a special dietary purpose. Trials involve a sponsor
(the person who designs and controls the study), an investigator (the person
who conducts the research), and a research subject (the person who is being
studied under the care of the investigator).
A convention has developed to describe clinical trials involving humans
as falling into one of four phases depending on the design of the study and
where the drug is in development. Phase I studies are generally conducted
in healthy volunteers and seek to determine the pharmacokinetics/pharma-
cological actions of the drug and the side eects associated with increasing
doses. Phase II trials seek to evaluate the preliminary ecacy of the drug
in patients with a medical condition of interest and to determine the side
eects and risks associated with the drug. Phase III trials, which tend to be
much larger studies, are conducted after preliminary evidence suggesting
that the ecacy of the drug has been demonstrated. As described in Chap-
ter , a brand-name manufacturer wishing to introduce a new drug to the
Canadian market will typically rely on Phase III clinical trials to obtain an
NOC. Finally, Phase IV studies are conducted using an authorized drug to
further study its use for one of its approved indications.
In , the FDA was amended to add a prohibition against conducting
a clinical trial without an authorization, as well as adding a power to make
CRC c , ss C.. & C...
 SOR/-.
 SOR/-.
See, for example, Health Canada, “Guidance Document for Clinical Trial Sponsors:
Clinical Trial Applications” (eective  May ), online (pdf): Government of
Canada www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/

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