EMEA speeds up drug assessment but still misses one statutory target

The European Medicines Agency (EMEA) showed a marked improvement in the time it takes to process drug applications but is still missing one of its statutory targets, the Agency's executive director has told APM.

In an interview, Thomas Lonngren said when the 2006 annual report is published later this year it will show that the average time taken by the CHMP to assess new drugs has fallen from 203 days in 2005 to 171 days in 2006.

This is well inside the 210 days statutory maximum for assessment. However, the post-CHMP opinion phase, which is used for translating documents and other procedural matters, is averaging 36 days, six more than the maximum laid down in EU legislation.

Lonngren said this was an improvement on the 56 days taken in 2005 and he promised that the 30-day target would be met in 2007. However, industry should not expect times to fall much more because ever more complicated new drugs meant the agency would have to work hard to meet it existing standards.

Citing research that suggests the EMEA and the US Food and Drug Administration (FDA) now take an almost identical time to approve a new drug, he said: "We should not expect the time to be too much lower, I am quite happy to be on par with the U.S. FDA."

He also noted this improvement comes against a much enlarged 2006 workload. The annual report will also show that last year the agency received 78 initial evaluation applications for new medicinal products, compared with just 41 in 2005.