Figures released by the 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 have been issued as of October 2010 compared with 117 in 2009.
Figures released by the 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 have been 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 8 in 2009.
All in all, it seems that there has been a significant decline in both started and finalised MA applications as a whole, reflecting drying industry pipelines. In 2009, the EMA started and finalized 95 and 125 MA applications respectively, compared with only 75 and 41 in 2010. The 2010 figures span January–October 2010 so obviously there’s still time for them to increase, but it seems highly unlikely that they will match those of 2009.
Despite views that pharma innovation and productivity has been lagging for some time, the figures show that MA applications to the EMA have actually been increasing, or at least remaining relatively stable, over the past few years. In 2007, the EMA started and finalised 90 and 65 MA applications respectively, and this 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). 2009 also saw a huge increase in the number of generic MA applications (38 started; 51 finalised).
For 2010, the decline in MA applications stretches across 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. However, we’ll probably have to wait until early next year before we know exactly what the full picture is for 2010. The EMA has also said that it will also provide commentaries and analysis of the figures in its own annual report.