At its July meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), the first vaccine for malaria to be assessed by a regulatory agency for use outside the European Union (EU).

Mosquirix was submitted to the European Medicines Agency (EMA) under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU. For more information on Mosquirix and the Article 58 procedure, please see the press release and infographic in the grid below.

In addition, ten medicines were recommended for marketing authorisation in the EU. The recommendations will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002373.jsp&mid=WC0b01ac058004d5c1