The European Medicines Agency (EMA) has updated its post-authorization guidance on how extensions of marketing authorizations and type II variations may impact orphan-designated medicines.
The updates follow the publication of a new notice by the European Commission on the application of Articles 3, 5 and 7 of Regulation (EC) No. 141/2000 on orphan medicinal products. In this notice, the European Commission provides guidance on the application of the Orphan Regulation, more specifically on orphan designation provisions.
EMA says that under the EC guidance, for a new therapeutic indication that falls under a previously confirmed orphan designation, EMA’s Committee for Orphan Medicinal products (COMP) will have to consider whether the specific scope of the variation raises justified and serious doubts in respect to the fulfillment of the orphan-designation criteria. EMA’s updated guidance is to be followed for applications submitted as of the date of publication of the commission’s notice, which was 18 November 2016.
Source: RAPS News & Trends
To read the full story go to http://www.raps.org/Regulatory-Focus/News
For assistance in submitting your regulatory documentation contact Samarind today.