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The regulations for new drug approval in Canada are found in the _Food and
Drugs Act_ (R.S.C. 1985 c. F-27, as subsequently amended), and in the
regulations pursuant to the act.  They are much too lengthy to copy and
fax.

Having said this, the real trouble is that I can't find any brief
explanation or commentary on the regulatory process of new drug approval
in Canada that gives step-by-step detail, or even a general overview, of
what the process involves.

I can find lots of commentary in journal articles on why various people or
groups don't like it, and lots of investigation (about three to five
years ago) into change that should be effected in the process (I don't
know if any of it was implemented), but I can't find a simple
explanation of the process.  I can access the web site of the Drugs
Programme (http://www.hwc.ca/hpb/drugs/htmleng/index.html) of the Health
Protection Branch (HPB) of Health Canada -- the folks in charge of the
process (I think) -- and find all sorts of downloadable (massive)
documents, but I can't tell which, if any, of them might be helpful.

Perhaps if you access the web site of the Drugs Programme of HPB you will
be able to communicate with them and get an answer to your question.  If
you get a simple answer of citation, please pass it along to me!
.....................................................................
Tom Flemming                    Internet: [log in to unmask]
Health Sciences Library         Ariel: 130.113.181.186
McMaster University             Voice: (905) 525-9140  x22321
1200 Main Street West           Fax:   (905) 528-3733
Hamilton, ON   L8N 3Z5

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