Strict regulations

for Canadian drugs

“*I’VE BEEN reading about a
new drug for arthritis which
is available im the United
States. Why can’t I get it in
Canada ?””

The availability of drugs in
Canada is governed by the
Health Protection Branch
(HPB), Department of Na-
tional Health and Welfare.

It takes years to get a new
drug onto the market,
whether in Canada or the
United States. Chemists may
test thousands of chemical
substances in the hope of
discovering one new drug.

There are extensive
laboratory tests. if the results
are promising, preclinical
testing follows. It consists of
trials on small groups of
volunteers.

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If good results are obtain-
ed, the manufacturer then
applies to the government for °
permission to conduct a
clinical (human) trial. The
new drug will be given to
more healthy volunteers who
are monitored closely for
adverse or toxic effects. If the
results of these safety trials
are at all unfavorable, the
drug must be reformulated
before further clinical trials
can proceed. These studics

can take many years to com- «si.

plete. One commonly
prescribed antibiotic was
studied and tested. for ap-
proximately 20 years before it
was ready for human usc.
When all of this testing os
satisfactorily completed, the
manufacturer then asks the
Drugs directorate for permis

Let’s take
care of

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sion No distribute the new
drug to “na » qualified in-
vestigators who will test it in
person having the disease
State or condition. for which
the drug is designed. If those
test outcomes are good, the
manufacturer files with the
government all information
known about the drug and
Study results. This document
is called ‘‘a new drug submis-
sion.’”’ It can be as short as
several pages or as long as
several hundred volumes.
Members of the Drugs Direc-
torate review the submission
thoroughly. If all is in order,

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the. manufacturer. is given
“permission to market the new
in Canada.

United States’ governments
conduct their new drug ap-
proval programs in-

United States are available in
‘Canada; for that matter, the
converse is also true. Further,
some non-prescription in the
United States.

An advisory column writ-
ten by The Canadian Phar-
maceutical Association, Ot-
tawa, Ontario.

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