EU CPMP October Meeting

The European Commission Committee for Proprietary Medicinal Products held its 20th plenary meeting 15-17 October at the European Medicines Evaluation Agency in London, followed by a preparatory technical meeting for the next International Conference on Harmonization Steering Committee.

The meeting adopted: - by consensus positive opinions (part A) for an antianemic, a diabetes treatment, a diagnostic and a vaccine against hepatitis A/B in children; - by consensus a positive opinion for a type II variation procedure concerning a European Marketing Authorization; - a Standard Operating Procedure: Centralized Procedure: From Assessment Reports to European Public Assessment Report (EPAR) (EMEA/SOP/005/96); and a position paper: How to Proceed With Specific Obligations and Follow-Up Measures for the Management of the Marketing Authorization (CPMP/725/96); - adopted three new scientific advice by consensus.

It noted that: - since its September meetings, the Commission has granted authorizations for Crixivan (indinavir), Olansek (olanzapine), Zyprexa (olanzapine), Invirase (saquinavir), Twinrix adult (combination vaccine), CEA-Scan (arcitumomab) and Indimacis 125. European Public Assessment Reports will be available; - four new applications have been assigned to rapporteurs and co-rapporteurs under the Centralized Procedure (two part A and two Part B); - nine new mutual recognition procedures and three type 1 and 10 type 11 variation procedures have been finalized. No new arbitration issues were raised; - a document, Best Practice Guide, has been adopted by the Mutual Recognition Facilitation Group and made available to the European trade associations;