E-drug: Drug approval criteria
----------------------------------------------------------
We are looking for examples of countries with criteria for drug approval
other than safety, efficacy, therapeutic index or good manufacturing
practice. Such criteria might include comparative safety, comparative
efficacy or cost-effectiveness. Please provide any references for these
examples.
Thanks so much
Peter Lurie, MD, MPH
Public Citizen's Health Research Group
1600 20th St., NW
Washington, DC 20009
Phone: (202)588-7781
Fax: (202)588-7796
Email: plurie@citizen.org
Website:http://www.citizen.org/hrg/
[Note from moderator: Countries such as Australia and Canada have guidelines
for cost-effectiveness studies and Norway has just made such guidelines for
how the studies should be performed - very much modelled on the Canadian
ones as far as I remember. Unfortunately, we have no need clause any more,
but in a way this is a substitute. And at least we do not have to reimburse
everything as we have a positive list for diagnoses (although recently it
has been too easy for companies to convince politicians to approve new drugs
on an individual basis, ignoring advice/recommendations from the Regulatory
Authorities and other professional bodies.) Kirsten Myhr]
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.