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Therapeutic Products Programme
Finance Building, Rm D112
Address Locator 0201C2
Ottawa, Ontario, K1A 1B9
August 1, 2000
To: Associations
Re: Medical Dictionary for Regulatory Activities (MedDRA) terminology document
MedDRA Term Selection: Points to Consider
MedDRA, an International Conference on Harmonization (ICH) initiative,
is an internationally accepted, clinically validated medical terminology
meant to standardize the terminology through which medical regulatory
information is classified, stored, retrieved, presented and communicated.
This terminology is intended to be used for regulatory activities related
to both pre- and post-approval phases. It will facilitate the transmission
of information using ICH E2B : Data Elements for Transmission of Individual
Case Safety Reports and ICH E2C: Clinical Safety Data Management: Periodic
Safety Update Reports for Marketed Drugs. Utilization of this standard
terminology for all stages of the products life cycle will reduce the
loss or distortion of information when communicated.
The aforementioned document was created to help pharmaceutical manufacturers,
clinical investigators and other users achieve consistency in the manner
in which they assign terms when using MedDRA. It is currently available
for comment through the MedDRA Maintenance and Support Services Organization
(MSSO) homepage http://www.meddramsso.org.
This is also the location where you can find information on MedDRA such
as costs, training and user group meetings. Please provide any comments
on the document directly to the MSSO. Comments may be submitted until
September 15, 2000.
Please note that the document is only available in English.
Should you have any questions please contact:
Heather Morrison
Adverse Drug Reaction Review and Information Unit
Bureau of Licensed Product Assessment
Therapeutic Products Programme, Health Canada
A/L 0201C2, Finance Building, D-112
Tunney's Pasture, Ottawa, Ontario, K1A 1B9
Tel: (613) 946-5137 Fax: (613) 957-0335
mailto: heather_morrison@hc-sc.gc.ca
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