A Bad Year for Pharmaceutical R&D

Dec 16, 2010

Figures released by the European Medicines Agency (EMA) regarding the evaluation of marketing-authorization (MA) applications show a significant decline in the number of approved products for 2010. Only 38 positive opinions were issued as of October 2010, compared with 117 in 2009. The number of negative opinions is also low, with just two issued so far this year compared with eight in 2009.

All in all, the number of started and finalized MA applications has declined significantly, reflecting drying industry pipelines. In 2009, EMA started and finalized 95 and 125 MA applications, respectively, compared with only 75 and 41 in 2010. The 2010 figures span the period from January through October 2010. The figures may yet increase, but it seems unlikely that they will match those of 2009.

Despite views that pharmaceutical innovation and productivity have been lagging for some time, the figures show that MA applications to EMA have actually been increasing, or at least remaining relatively stable, over the past few years. In 2007, EMA started and finalized 90 and 65 MA applications, respectively, and these numbers increased in 2008 to 103 and 72 applications. In 2009, there was a slight decline in started MA applications (down to 84), but a major increase in finalized applications (114). Also in 2009, there was a huge increase in the number of generic MA applications (38 started and 51 finalized).

For 2010, the decline in MA applications encompasses both new products and generics and is particularly marked in finalized applications. Only 18 applications were finalized for new products (down from 49 in 2009) while generics applications dropped to 15.

The EMA has said that it will provide monthly updates on its website concerning the volume and evaluation of MA and post-authorization applications. The full picture for 2010 will not be clear until early next year, however. EMA also said that it will provide commentaries and analyses of the figures in its own annual report.

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