E-drug: Globalization of the drug market /ICH (cont)
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I fully agree with Patrice Trouiller - ICH and the EMEA can never be
"gold standards" because they are the result of an international
compromise. When the EMEA regulations came in force the
Northwestern European countries (i.e., the UK, Scandinavia and
Holland) had to sacrifice a lot of gold, but in contrast the quality of
drug registration in the Mediterranean countries improved - some
lost, some gained. It is what has been called in Holland the "polder
model" of full consensus. We used to have real "gold standards" like
the Australian and the Swedish systems, but as a result of this
"globalisation" some quality was lost.
ICH is good for industry, whether it is good for patients remains in
doubt.
Best wishes,
Dr.L.Offerhaus
Koedijklaan 1a, NL-1406KW Bussum, The Netherlands
Phone: +31-35-6923288. Fax: +31-35-6923290
E-mail: LO@EURONET.NL CompuServe: 71530,15
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