Dear Gerald,
Even if there were such a source, it would be out of date very
quickly indeed. IDRAC says that they offer a service for this
(<http://www.eu.imshealth.com/idrac/>http://www.eu.imshealth.com/idrac/)
but it is very expensive and in my personal view does not offer much
more than published guidance etc.
Alternatively, of course, there are certain regulatory consultancies
able to obtain current information on this for you. One in
particular comes to mind...
Hope things are going well up there for you, and congrats on getting
your EMEA approval through.
Cheers,
Peter Lassoff, Pharm.D.
Associate Director
Worldwide Regulatory Affairs
PAREXEL International Ltd.
River Court, 50 Oxford Road
Denham, Uxbridge, Middlesex
UB9 4DL, UK
Tel: +44 1895 614427
Fax: +44 1895 614375
Mobile: +44 7740 899 222
<mailto:Peter.Lassoff@PAREXEL.com>mailto:Peter.Lassoff@PAREXEL.com
<http://www.PAREXEL.com/>http://www.PAREXEL.com/
-----Original Message-----
From: gfarmer@scotia-holdings.com
[<mailto:gfarmer@scotia-holdings.com>mailto:gfarmer@scotia-holdings.com]
Sent: 30 July 2001 14:47
To: RegAffairs
Subject: Regulatory Requirements
Does anyone have, or know where I could access a comprehensive list of the
various requirements for submissions in Latin America, Eastern Europe,
Middle and Far East. By comprehensive, I mean details on, for example, the
need for local clinical trials, if the studies must be ongoing or complete
at time of submission, the need for and timing of delivery of samples,
local agent requirements, submission fees, likely time of approval, local
language requirements for the various parts of the dossier, the timing of
the certificate of free sale (needed for submission or can be provided
prior to approval) etc
many thanks
Gerard Farmer
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