EMEA Implements Wave of Changes

January 1, 2010

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-01-01-2010, Volume 0, Issue 0

The EU's regulatory agency aims for efficiency with recent changes.

The New Year has seen the introduction of a fresh regime at the European Medicines Agency (EMEA). Amendments to the agency's organizational network, fee structure, and Web presence take effect this month.

Among the highlights of the new system is the integration of human pre- and postauthorization activities into one unit. The move is designed to guarantee seamless lifecycle management of medicines. In addition, the creation of a unit for patient health protection aims to strengthen the EMEA's focus on drug safety monitoring, and a dedicated group for the management of product data and documentation should help to improve the efficiency of data management processes (a chart is available at http://www.ema.europa.eu/pdfs/general/direct/organisation.pdf).

Package of change

Since EMEA was established in 1995 as a decentralized body of the European Union with its headquarters in London, this is only the second major reorganization. The agency now brings together the scientific resources of over 40 national competent authorities in 30 countries in a network of more than 4500 European experts. It has a secretariat of approximately 530 staff members, whose responsibilities and tasks have grown immensely, giving it a stronger role in the protection of public and animal health in Europe, according to Executive Director Thomas Lönngren.

"This package of changes aims at preparing the agency for the future," he noted. "The new structure reinforces our operational ability to deliver on our increasingly complex tasks, and our new visual identity will help to improve the quality and consistency of our communications with our partners and the public."

The EMEA's growth has been underpinned by the creation of additional scientific committees and advisory groups, which bring with them the need for enhanced coordination and support, said Lönngren. Legislative proposals currently being considered by the European Parliament and Council are expected to bring further responsibilities to the agency.

The EMEA has also revised its rules on fees, which came into effect on January 1, 2010. They are relatively complex and will require careful scrutiny by industry, and they take into account the changes introduced by the new Variations Regulation (EC) No 1234/2008. Full details are available at www.ema.europa.eu.

The EMEA's total budget for 2010 has been fixed at €198,187,000, ($289.8 million) compared with €194,389,000 in 2009. This includes forecast fee revenues of €152,780,000, against €140,966,000 in 2009, and a total EU contribution of €37,112,000. The addition of 37 new recruits has also been approved.

The agency's priorities for the year ahead include strengthening the European medicines network, cooperating with international partners, fostering transparency and provision of information, and stimulating innovation and improved availability of medicines.

Later this month, EMEA will release a draft road map for the next five years (2011-2015). The document will be open to three months' public consultation. The road map focuses on improving the operation of the core business, addressing public health needs, facilitating access to medicines, and optimizing the use of medicines.

A new public Web site for EMEA is nearing completion and will be launched over the coming months. The new site is being designed with the needs of the public in mind, offering improved navigation and search functionality and providing better access to data on public health issues.

E-mail addresses for staff have also changed, and are composed as follows: 'forename.surname@ema.europa.eu.' Messages sent to old e-mail addresses will continue to be delivered for the next year. Finally, reference numbers for the Agency's documents will change from "EMEA/123456/2010" to "EMA/123456/2010." The change will not have an impact on the sequence number or year index where an existing document is revised and republished.—Philip Ward

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