EU CPMP December Plenary Meeting

The European Union Committee for Proprietary Medicinal products held a plenary meeting on December 19-20, 1995, at the European medicines Evaluation Agency in London, followed on December 21 by sessions on scientific advice requested by companies.

The meeting adopted a positive opinion by consensus on one new active substance (ex-concertation procedure), for forwarding to the Commission for authorization. Eight active substances have been adopted from ex-concertation procedures since May 1995; Gonal F (follitropin alpha), Taxotere (docetaxel) and Betaferon (interferon beta-1b) have been authorized.

"Strong" Suggestion On Selection of Rapporteurs In 1995, 30 new applications covering 26 new active substances were assigned to rapporteurs and co-rapporteurs under the centralized procedure following identification (nine A and 21 B). The CPMP agreed that in future it may not always be possible to follow the applicant's suggestion in these appointments. To avoid an imbalance between CPMP members in their appointment and acceptance, it strongly suggested that future applications should make three or four proposals for either rapporteur or co-rapporteur.