The European Commission has now published its updated Notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products which in particular addresses the concept of “significant benefit”.
- Satisfactory method authorised in the Union – Article 3(1)(b) of Regulation 141/2000 requires the sponsor to establish that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the European Union
- Re-evaluation of orphan designation criteria at time of marketing authorisation — preauthorisation phase
- The new Notice addresses the situation where two MA applications for the same condition are pending with the EMA but where these proceedings not remain in parallel
- Designated condition versus authorised indication
The Commission consultation document also discussed the reassessment of the orphan criteria for a new subset of the condition when a sponsor extends the use of its product after marketing authorisation.