European Medicines Agency says it has seen strong level of applications in 2007

The number of applications for pharmaceutical product marketing authorizations submitted to the European Medicines Agency (EMEA) remains strong, according to the half-year report presented to the Agency's Management Board by Thomas Lonngren, EMEA Executive Director, at its meeting earlier this month.

The Agency had received a total of 42 applications by mid-2007, with a further 52 forecast by the end of the year. This follows the record number of applications made to the EMEA in 2006. One area of growth is submissions for "biosimilar" medicines (copy products of biotechnology-based drugs), with eight filings made in the first half of 2007 and a further eight expected by the end of the current year.

Reviewing the Agency's implementation of the 2007 work program, the Board highlighted two major achievements from the first half year. One is the Agency's progress on implementing the new Pediatric Regulation, including the successful establishment of the Pediatric Committee (PDCO). The other is the roll-out of a new data analysis system for EudraVigilance, the European pharmacovigilance data-processing network management system, to all competent authorities in the European Union member states, which has significantly improved the systems capabilities to monitor the safety of medicines, the report claims.