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The European Commission has opened a public consultation to gain views from stakeholders on proposed revisions to EU regulation on orphan medicines, especially in respect of how the concept of 'similar medicinal product' is understood. The consultation closes on 4th November 2016.
A short four-page document explains the rationale for the proposed changes. Fifteen years after EU regulations on orphan medicines were put in place, changes in science, technology and the pharmaceutical market has caused a rethink in how the concept of ‘similar medicinal product’ is understood when it comes to applying the various incentives provided by designation of a product as 'orphan' (ie, intended for treatment for rare conditions). Developments in respect to biological medicines and Advanced Therapy Medicinal Products (ATMPs) are …
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.