The Year to Come: EMA's Plans Announced

At the end of last month, the European Medicines Agency approved its budget and work program for the coming year, promising to implement measures to increase operational efficiency, enhance transparency and communication with stakeholders, and improve the quality and consistency of rulemaking. With a 4.1% increase in budget to €231.6 million and an anticipated 54 new medicines for review in 2013, up from 52 in 2012, the agency is facing more pressure to maintain performance goals amid an unprecedented period of fiscal austerity. Industry expects more from the agency as well.

In fact, the major priority in 2013 will be an intensive internal review of all key functions, including the seven scientific committees responsible for new drug approvals .The goal is to optimize current procedures, eliminate potential conflicts of interest through policy and monitoring, and by coordinating operations across committees, task forces and work groups.

Legislatively, the agency will prepare guidelines for patient reporting, launch an intensive program of pharmacovigilance inspections and increase communication with stakeholders. It also plans on working with NCAs on a Union-wide database of good manufacturing and distribution practices in the context of a new initiative to assure responsibility for monitoring and policing trade in falsified medicines, which begins in January.

Transparency is of utmost importance, as the agency continues to reshape its image in efforts to gain the public’s confidence. To that end, it will publish agendas and minutes of all its scientific committees by the end of 2013. It also plans to engage with stakeholders in a series of consultations to finalize a commitment to “proactively” release all clinical trial data submitted in pursuit of a licensing authorization by 2014.

Overall, the agency knows it must gear up its efficiency to avoid being a target of budget cutbacks at a time when the Eurozone faces stagnation from the ongoing fiscal crisis. One of the proposed measures for tightening operations is the enactment of a new information and communication technology (ICT) strategy to allow for more timely and cost effective transfer of data between different parts of the organization.