EMA reports on decision-making for orphan medicines

The European Medicines Agency (EMA) has started publishing orphan maintenance assessment reports for all orphan-designated medicines recommended for marketing authorisation. The first report published 17th January 2018 covers Prevymis, an antiviral medicine.

The report summarises the EMA’s Committee for Orphan Medicinal Products (COMP) approach on whether a medicine designated as an orphan medicine during its development still fulfils the designation criteria at the time of its authorisation. This is a precondition for the medicine to benefit from ten-year market exclusivity, one of the incentives of the European Union (EU) orphan programme.

COMP opinions covering positive, negative or withdrawal opinions are published in the report. This also describes the orphan condition and its seriousness, the spread of the condition at the time of maintenance of the designation, and if applicable, the significant benefit over already authorised medicines.

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Published 19. January 2018 in News EU