The European Commission has finally published the draft amendment to Regulation No 847/2000 regarding the concept of “similar medicinal product” for the purposes of the Orphan Medicinal Products Regulation. A key incentive of this Regulation is the ten-year market exclusivity that protects an orphan medicinal product, whereby national competent authorities shall not accept an application for authorisation, or grant an authorisation, or accept an application to extend an existing authorisation, “for the same therapeutic indication, in respect of a similar medicinal product” as the orphan product. Regulation 847/2000 defines “similar medicinal product” in this context, and sets out a number of examples of what kind of products will be similar.

Following a consultation last year, the Commission intends to make changes to the 17-year-old text to account for the rise of cell therapies and other advanced therapy medicinal products, the nature of which do not fit neatly into the current definitions.Continue Reading Draft Regulation amending definition of “similar medicinal product”