Clinical trials must adhere
to the principles of the Declaration of Helsinki and Good Clinical
Practice. Prior to conducting a clinical trial in Israel, approval
must be obtained from an Institutional Review Board (Helsinki Committee);
in some cases, approval from the Israeli Ministry of Health (MOH)
is also required.
A clinical trial application has to be submitted to the appropriate
Helsinki Committee. The committee usually makes its decision within
2 months. If MOH approval is also necessary, the Helsinki Committee
(in a multicentre trial, the first Helsinki Committee to approve)
will then forward the application to the Pharmaceutical Administration
of the MOH for approval.
There is no central ethics committee in Israel; hospitals have their own Helsinki Committees. In 1999 Israeli public health regulations were amended and new guidelines concerning clinical trials in human subjects were issued. Authority was delegated to the Helsinki Committees of the hospitals, empowering them to approve the study protocol in the cases of "special" (known-risk) clinical trials, without additional approval by the MOH. The approval process is now shorter for such "special" clinical trials, going directly from the Helsinki Committee to the director of the hospital.
"Special" clinical trials are, for example, studies of medicinal products registered for sale in Israel or already approved for marketing in a recognised country (i.e. USA, EU, Australia, Iceland, Japan, New Zealand, Norway, Switzerland), and efficacy studies of medicinal products for which corresponding safety studies have already been successfully conducted in one of the recognised countries. The product has to be used for the approved indication in the normal dosage.
"Other" clinical trials not falling in the category of "special" clinical trials require MOH approval.
For detailed information about clinical trials in Israel please refer
to Ahuva Koren's article published in MONITOR in February 2007 view
article
It should be borne in mind that Fridays are holidays in Israel and
Sunday is a working day.
 Health
Care System |
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Israel is a country of immigrants, with a diverse population
of about 7 million inhabitants who have varied ethnic backgrounds,
cultures and religions. The majority, about 80%, are Jewish.
About one third of the population are children under 18.
Health insurance is compulsory for all residents of Israel. The National Health Insurance Law, which came into effect in 1995, provides relatively comprehensive basic health services to all citizens. Health services for young children are well-developed; there is a nationwide network of Mother and Child clinics. Privatisation has been increasing to satisfy growing demands.
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Local
office/staff |
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ECRON / GCP Clinical Studies Ltd.
22 Hamelacha Street, Rosh Ha ayin 48091, Israel
Phone: +972 (3) 9002003, Fax: +972 (3) 9027138
Email: bd@ecronacunova.com
or contact GCP Clinical
Studies Ltd. for further specialized service
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ISRAEL
