EMEA outlines challenges for regulators and drugmakers in the EU

The European Medicines Agency (EMEA) has outlined its vision for the future with special emphasis on how the regulatory agency helps to bring new medicines to market and the more proactive pharmacovigiliance approach taken in recent years. In front of a gathering of journalists at the EMEA's London, UK headquarters, the agency's Executive Director, Thomas Lonngren, was joined by senior members of the agency to give presentations about selected areas of its activities.

Mr Lonngren reiterated the EMEA's priorities for 2008, which were also reported when the regulatory body's work program for this year was published (Marketletter March 17). The Agency projects a 12% increase in the number of initial applications for marketing authorizations for human medicines - up to 102 applications. Strong growth was also forecast in the number of requests for scientific advice for human medicines, with more than 360 anticipated.

Patrick Le Courtois, the head of the EMEA's pre-authorization evaluation of medicines for human use unit, said that the agency is on track to achieve its goals, in terms of approvals and both scientific advice and protocol assistance, two areas where the regulator considers itself to offer a relatively business-friendly service. Dr Le Courtois noted that the agency's Innovation Task Force has advanced from four briefings to companies in 2004 to 19 last year. For the five months to May 2008, the trend is on track to match or surpass the 2007 performance, with eight briefings. A separate indicator of the EMEA's activities is the number of regulatory advice meetings organized in the same time frame. From two in 2004, there has been a more than 10-fold increase to 24 in 2007 and, by the end of May 2008, there were already 15 regulatory briefings to drug firms.