EMA Highlights 2009 Accomplishments and Looks Ahead

The European Medicines Agency’s Management Board highlighted and praised the European medicines regulatory network's handling of the 2009 H1N1 swine-flu pandemic, according to a Mar. 26, 2010 press release. Meeting last month, the board noted that the network allowed the agency, now known as the EMA, to contribute to the European Union response with timely scientific opinions that lead to the approval of three pandemic vaccines and new recommendations for antiviral medicines, says the release.

EMA also noted that it witnessed substantial increases in core areas throughout 2009, including scientific-advice requests (20%), orphan designations (38%), Type II variations (20%), and safety-related activities. The number of applications for marketing authorizations for medicines for human use received was 60% higher than expected.

Looking ahead, the executive director of the EMA board noted several priority items for 2011. According to the release, these include: efficient management of the core business; monitoring of the safety of medicines and ensuring continuous positive benefit-risk balance; continued involvement of patients and healthcare professionals; responding to globalization of manufacturing and research activities; and responding to public health needs, such as antimicrobial resistance and medicines for the elderly. In addition, EMA intends to further increase transparency of its daily operations by publishing minutes of scientific committee and working-party meetings.

EMA expects 52 marketing authorization applications for new medicines and 56 applications for generic and hybrid medicines in 2011, as well as 170 applications for orphan designation. The management board’s draft budget for 2011 is € 218.9 million (approximately $294 million), an increase of €20.7 million from 2010.