EMA says applications for new drugs up 40% in 2011

08/06/2012

Applications for new medicines to the European regulator increased by over 40% in 2011, according to figures in the organisation's annual report.

In the report published on Wednesday, the European Medicines Agency (EMA) showed the number of new medicinal product applications in 2011 was 48, compared with 34 in 2010 and 36 in 2009.

At the same time, the number of generic applications slid because of a tightening in rules governing duplicate applications, from 48 in 2009, to 43 in 2010 then to 34 in 2011.

The number of applications for orphan products increased slightly (2009 - 11 applications, 2010 - 12, 2012 - 14), while for biosimilar medicines the EMA received only two applications in 2009 and 2010 inclusive and three in 2011.

Musculoskeletal (26 applications) was the most popular therapeutic area, followed by alimentary tract (17 applications).

In a statement, the Association of the British Pharmaceutical Industry (ABPI) welcomed the figures, but cautioned that the UK government must do more to incentivise the industry to produce more medicines.

An ABPI spokesperson told APM: "We are pleased to see an increase in new medicinal applications to the EMA, but the government needs to continue do all it can to incentivise the life sciences industry.

"A range of initiatives, such as the Patent Box or the recommendations in last year's Innovation, Health and Wealth review have been positive, but it is essential our next pricing scheme rewards innovation and encourages further R&D to take place in the UK."

The EMA announced on Thursday that the European Commission had issued the 1000th orphan medicine designation following a recommendation from its Committee for Orphan Medicinal Products.

Source: www.apmhealtheurope.com