The European Medicines Agency (EMA) released an updated version of its post-authorization guidance on the effects of extensions of marketing authorizations and type II variations on orphan-designated medicines.
Among the contents of the document are:
- Consideration of EMA’s Committee for Orphan Medicinal products (COMP) whether the specific scope of the variation raises justified and serious doubts in respect to the fulfillment of the orphan-designation criteria for “new therapeutic indication under a previously confirmed orphan designation”
- Confirmation by COMP of the maintenance of the orphan designation before authorization of the new indication for a “new therapeutic indication under a new orphan designation”
The guidance was released on November 18, 2016.