All Orphans Must Get 10-Year Exclusivity, Says Top EU Court
This article was originally published in SRA
In a judgment that upholds a central tenet of Europe's Orphan Drug Regulation, the Court of Justice of the EU has ruled that all orphan medicines are entitled to a full 10-year period of market exclusivity, even if they have been approved as "similar" to an existing orphan drug1.
You may also be interested in...
The European Commission has proposed changes to the existing criteria used for determining whether a new medicinal product is similar to an already authorized orphan drug and, therefore, whether it can be accepted for evaluation and granted 10-year market exclusivity.
Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.
A “powerful new vision” for the post-Brexit UK regulatory framework was unveiled at a conference organized by the BioIndustry Association and the medicines regulator, the MHRA.