Mary,
From my reading of the regulations I understand the following:
1. Each trial needs MOH approval unless it is a "special trial"
2. A special trial is: a) one involving a drug previously approved in
an "approved country" (US, etc.) and at the approved dose; b) for
efficacy only if safety has been proven in an approved country and
full details reported in the Investigator's Brochure, c) additional
sites if the protocol has been previously approved by the MOH, d)
Bioequivalence for generics
Regards,
Peter Geffen
Regulatory Affairs
D-Pharm Ltd.
P.O.Box 2313, Rehovot 76123, Israel
Tel. 972-8-940.4646 Fax. 972-8-940.4446
<mailto:pgeffen@dpharm.com>mailto:pgeffen@dpharm.com
-----Original Message-----
From: Mary Jarosz [<mailto:mary@jrsweb.com>mailto:mary@jrsweb.com]
Sent: Tuesday, November 13, 2001 11:57 AM
To: RegAffairs
Subject: Clinical Trials Israel
An investigator in Israel for a US-based pharmaceutical company had
previously submitted regulatory documentation for a new chemical
entity and had conducted two previous clinical studies in Israel.
The company is starting another trial in Israel with the same drug
for the same indication but another protocol. The investigator
claims since he has already registered with the MOH for the previous
studies, he does not need to send the MOH any further information
regarding the new study. He only needs to apply for ethics approval.
Is this consistent with clinical requirements in Israel?
Regards,
Mary Jarosz
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Mary Jarosz
mary@jrsweb.com
Jarosz Regulatory Services, Inc.
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