Don't expect any sudden burst of productivity in the R&D field. Regulators at the EMA say they expect to receive applications for 42 new drugs for human use in 2011, just two more than it gathered this year. And there should be a total of 97 apps, the agency adds, if you include generic drug filings and more. Last year the EMA fielded a total of 95 apps.
Getting those drugs reviewed, though, will cost more. Industry fees should ring up at €161 million, says the agency, up from €152 million in 2010. The EU's share, meanwhile will drop from €39.1 million to €33.5 million.
The sparse number of new drug applications filed each year has proved a severe challenge for the world's drug development industry. The outgoing head of the EMA recently sparked controversy with his opinions on the stark lack of success in drug development despite a collective budget of $85 billion a year.
"How many [new drugs] are approved each year-six, seven, eight, nine maybe? If the value of these few new drugs is worth 10, maybe 20 billion U.S. dollars, then where is the remainder of the $85 billion going?" asked Thomas Lonngren, who is wrapping up a 10-year stint at the agency. "Maybe we could use this $60 billion in a better way?"
- here's the Reuters report