EMA Recommends 39 Drugs in First Half of 2014 - - BioPharm International


EMA Recommends 39 Drugs in First Half of 2014

Thirty-nine drugs were recommended for marketing authorization by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in the first half of 2014, compared with 44 in first half of 2013 and 33 in first half of 2012. The recommended drugs included drugs designed to fill unmet medical needs, treat diseases for which no treatments were previously available, or bring significant added benefit to patients over existing therapies. The number of new medicines intended for the treatment of rare diseases increased, with eight drugs recommended for the treatment of rare diseases in the first half of 2014. The number of drug products recommended for approval via the European Union centralized procedure based on generic or informed consent applications, however, has decreased compared with the first half of 2013 (6 versus 13). 

More than two in three applicants received scientific advice from the CHMP during the development phase, and for innovative medicines, four in five applicants received such advice, a significant increase compared with the first half of 2013. This trend is in line with the growing number of requests for scientific advice received by EMA.

Source: European Medicines Agency

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