US To Accept Israeli Clinical Trials

13 November 1995

US Food Food and Drug Administration Commissioner David Kessler has confirmed formally to the Israeli Ministry of Health that the FDA will recognize clinical trials carried out in Israel. This follows the recent successful training programs in Good Clinical Practice. Israel and Sweden are believed to be the only two countries that have this recognition at present (Switzerland has had it in the past but it is not in force at the moment).

At present, there are about 900 drug and 100 device/diagnostic kit trials being carried each year in Israel, most of them without any connection to FDA approval. According to Israel's Health Minister, Ephraim Sneh, this recognition is a major scientific and economic achievement that is expected to raise the quality and funding of research in his country. The implementation of the agreement will be monitored by visiting FDA inspectors as well as by FDA-trained inspectors at the Israeli MoH.

Adjustments To Index Of Health Costs Proposed Meantime, with the new budget in mind (but ahead of the news that the country's Prime Minister Rabin had been assassinated), Dr Sneh suggested that the index of health costs be adjusted so as to reflect elements which have a direct impact on the growth in expenditure, such as population growth, an increase in the aged population and escalating technological costs of health services. Inclusion of these three elements in the health costs index would result in a real increase for the 1996 budget for the basket of services of around 6%.

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