EMA Outlines Work Program for 2011 and Adopts New Five-Year Plan - Pharmaceutical Technology

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EMA Outlines Work Program for 2011 and Adopts New Five-Year Plan


ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency outlined its work program and budget for 2011. The agency anticipates similar workloads for drug applications and practically no increases to its budget for that work program in 2011. EMA also formally adopted a five-year plan that outlines the agency’s strategy and announced increased cooperation with the European Center for Disease Prevention and Control (ECDC).

EMA’s management board adopted the agency’s work program and related budget for 2011 at its meeting on Dec. 16, 2010, according to a Dec. 21, 2010 EMA press release. The work program forecasts a stable number of applications for marketing authorizations for human and veterinary medicines in 2011.

EMA expects approximately 97 applications in 2011, up slightly from 95 applications in 2010. EMA anticipates 40 applications for new medicines for human use, 12 applications for new orphan medicines, and 42 applications for generic drugs. In 2010, EMA received 38 applications for new drugs, 14 applications for orphan drugs, and 41 applications for generic drugs. EMA also expects to receive 18 applications for new veterinary medicines. The 2011 work program will be published in January 2011.

EMA’s work program is accompanied by a budget of EUR 208.9 million ($274.0 million), an increase of only 0.23% compared with 2010. The 2011 budget includes fee revenue of EUR 161 million ($211 million) and an contribution by the European Union of EUR 33.5 million ($43.9 million). The special orphan medicine fund given by the EU has been reduced from EUR 8.2 million ($10.7 million) to EUR 4.9 million ($6.4 million). No new staff posts are foreseen for 2011, with the staff ceiling fixed at the 2010 level of 567 temporary agents, according to EMA.

EMA’s management board also adopted the “Road Map to 2015,” which outlines the EMA’s strategy for delivering the agency’s core activities and three priority areas of  strengthening the agency’s role in addressing public health needs, facilitating access to medicines, and optimizing the safe use of medicines. Then agency’s previous five-year plan ended in 2010. The Road Map to 2015 will be published in January 2011. EMA had a public consultation for the new five-year plan during the first half of 2010 and considered responses from 71 stakeholders, including EU institutions, member states, and organizations representing patients and consumers, healthcare professionals, the pharmaceutical industry, academia, and health technology assessment bodies, according to EMA.

In other news, EMA signed a working arrangement to increase its cooperation with the ECDC. The new arrangement became effective Dec. 16, 2010, and includes several areas of cooperation as follows:

  • The exchange of information on vaccines, antimicrobial resistance, and antiviral medicines
  • Monitoring the benefit-risk balance of vaccines
  • Collaboration on substances of human origin, such as the use of human tissue or cells in medicines
  • Participation in meetings and joint projects.

EMA been working with the ECDC for several years, notably during the 2009 influenza pandemic. The new agreement extends that collaboration.

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