European medicines licensing applications start to recover
Applications for new European marketing authorisations are rising again, after nearly halving between 2001 and 2002.
There were 39 applications in 2003, compared to 31 in 2002 and 58 in
2001. The increase has been welcomed by the European Agency for the Evaluation
of Medicinal Products (EMEA), which had been worried about the possible
public health consequences of a lack of new medicines.
The drop in 2002 applications was so great that the EMEA and the European
Commission launched an investigation to find out what had happened. They
concluded that it was a global issue for which drug regulators were not
primarily responsible. Possible factors included company mergers, failure
of new technologies to deliver on time and overemphasis on blockbuster
drugs.
The figures are given in the agency’s annual report for 2003, which
also records an increase in pharmaceutical company requests for scientific
advice from the EMEA. The report says that data show the positive impact
that seeking advice has on the time taken to review applications and
on review outcomes. |
The
Pharmaceutical Journal
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