Posted by Michael Wonder on 17 Jan 2018
Is an orphan medicine still an orphan once it gets on the market?
17 January 2018 - EMA publishes additional reports on decision-making for orphan medicines; initiative addresses requests from stakeholders.
The EMA will be publishing, as of today, a so-called orphan maintenance assessment report for every orphan-designated medicine which has been recommended for marketing authorisation by the Agency.
The new report summarises the reasoning of the Agency’s Committee for Orphan Medicinal Products on whether or not a medicine designated as an orphan medicine during its development still fulfils the designation criteria at the time of its authorisation. This is the precondition for it to benefit from ten year market exclusivity, one of the incentives of the European Union orphan programme. The report will be published as part of a medicine’s European Public Assessment Report once the European Commission has adopted its marketing authorisation decision.
