Brussels, 18/04/2013 (Agence Europe) - On 16 April, the European Medicines Agency (EMA) published its annual report. It reveals the growing complexity of authorisation requests received, the rise in demand for orphan medicines and the rise in demand from SMEs.
According to the annual report, the number of requests EMA received last year for marketing authorisation approval (MAA) for medicines destined for human use remained stable, with a total of 96 requests. The EMA human scientific committee's working party with patients' and consumers' organisations (PCWP) issued 59 favourable opinions for approval of new medicines, especially for the first gene therapy in Europe. Compared to 2011, there was a 36% rise in the number of MAAs for orphan drugs (intended to treat illnesses that do not affect over 5 people out of 10,000 in the EU), i.e. 19 requests in total. According to the EMA, recent incentives provided for in the European legislation for research on orphan medicines explains this upward trend. In 2012, 148 designations of orphan medicines were granted compared to 107 in 2011 and over 150 are expected in 2013. Furthermore, the number of SMEs having submitted an MAA has increased and represents 30% of requests submitted. Also, SMEs accounted for the most MAAs for orphan medicines: 68% compared to only 27% in 2011. In the veterinary field, EMA received 12 requests for evaluation of new veterinary products last year. Only 25% of the applications concerned animals for food production whereas 75% were intended for domestic pets. This is a significant change as, in 2011, requests were balanced (50/50). (IL/transl.jl)