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www.fdanews.com/articles/84894-israeli-patients-take-action-over-drug-registration-delays

ISRAELI PATIENTS TAKE ACTION OVER DRUG REGISTRATION DELAYS

February 28, 2006

The Society for Patient's Rights in Israel is planning to bring a lawsuit against the health ministry for failing to register 330 medicines. The society claims that the registration process in Europe and the US is far quicker and that the Israeli system is in need of reform.

The Ministry of Health is charged with ensuring that drugs sold in Israel are safe and effective and of a high quality. However, the society claims that registration takes too long, as the ministry does not have the resources to test drugs itself. Therefore, it is calling on the High Court to rule that drugs already authorised by the US FDA and European regulators can be automatically approved in Israel.

Of the disputed medications, 78 have been awaiting approval since 2004. However, the authorities assert that only 25 of these drugs are lifesaving and that Israeli patients can receive special approval for the personal import of unregistered drugs if a doctor files an application.