Press Release: Commission allows early authorisation for emergency medicines

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Series Details IP/06/463 (6.4.06)
Publication Date 06/04/2006
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In order to ensure that new treatments reach patients faster, the European Commission on 6 April 2006 decided to speed up the authorisation of newly developed drugs for life-threatening diseases under strict conditions. These new Commission rules would maintain high safety standards, while allowing patients with unmet medical needs to receive new treatments earlier during product development. The new rules would allow medicines to enter the EU market using a so-called ‘Conditional Marketing Authorisation’ which was to be valid for one year and legally bind companies to complete studies to confirm the medicine’s safety and effectiveness.

Source Link http://europa.eu/rapid/pressReleasesAction.do?reference=IP/06/463&format=HTML&aged=0&language=EN&guiLanguage=en
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