The EMA protocol assistance is the scientific advice of the Committee for Human Medicinal Products (CHMP) along with Committee for Orphan Medicinal Products (COMP), particularly designed for products that have orphan drug designation status.
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EMA Protocol Assistance (i.e., Scientific Advice for Orphans)
Published by IRDiRC
Regulatory AffairsEarly Access SupportScientific AdviceCommittee for Orphan Medicinal Products