EMA expects lower rate of generic applications; Issues guidelines on schizophrenia and MS

In its mid-year report for 2012, the European Medicines Agency’s management board yesterday provided an overview of the Agency’s progress from January to June in implementing its 2012 work program, with executive director Guido Rasi saying that the progress of the Agency’s activities so far in 2012 was encouraging. "Our main performance indicators have been met. The mid-year report indicates that the Agency is on target to meet its core business objectives for 2012," he said.

The number of new marketing authorization applications for new human medicines received so far is largely in line with 2011 figures for the same period (52). However, the forecast for applications to be submitted by the end of the year has been reduced from 112 to 101, owing mainly to a lower rate of submission of applications for generic medicinal products for human use than expected.

The board noted that requests for scientific advice and protocol assistance for new human medicines had increased by almost 14% and 24%, respectively, compared to figures from the same period in 2011, confirming the growing importance for pharmaceutical companies to seek early advice from the Agency on their medicines-development programs. The report also showed a significant increase in the number of applications for orphan designation (30% above the same period in 2011).