As reported in our previous post, at the end of last year, the European Commission published a draft amendment to Regulation No 847/2000 regarding the concept of “similar medicinal product” for the purposes of the Orphan Medicinal Products Regulation. Last week, the final Regulation was published: Regulation (EU) 2018/781. The new Regulation is intended to take account of the rise of cell therapies and other advanced therapy medicinal products, the nature of which do not fit neatly into the current definitions.
The final Regulation is very similar to the one released for consultation, with a few minor clarification points added, namely to specifically refer to changes with respect to safety, as well as intended therapeutic effect, when considering whether two advanced therapy products are similar.
The Regulation will enter into force on 19 June 2018.