Compassionate use programmes for rare diseases: proposals for actions
نویسندگان
چکیده
Aims Patients’ advocates, regulators and doctors have the constant objective to make the best treatments quickly available to patients. Compassionate use programmes (CUP) as defined by the EU Regulation (EC) No 726/2004 article 83.2 are designed to provide early access before the marketing authorisation (MA) of a medicine. It is necessary to evaluate the achievements of the present legislations on CUP in Europe in order to propose actions that could integrate CUP into an improved orphan drug development model.
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عنوان ژورنال:
دوره 7 شماره
صفحات -
تاریخ انتشار 2012