EMEA Outlines New Long-Term Strategy

As part of its "Road Map to 2010," the European Medicines Agency (EMEA) and European Union (EU) national drug regulators have published a new set of strategic plans. In the future, the EMEA's powers are likely to include greater control over detecting and reducing public health risks. A series of new measures, due to become fully effective from November 2005, are set to provide the legal basis for the body's growing authority.

The EMEA implemented significant earlier pharmaceutical legislation in May last year, but November's provisions will transfer some powers away from national regulatory agencies. Conditional approvals and fast-track reviews will become the EMEA's responsibility, and moves are in place to improve transparency and efficiency. In one example, the agency's management board will be slimmed down to 33 member-state officials, medical experts and patients' representatives.

Notably, the EMEA will have far more power to intervene in cases where "the risk-benefit balance" of a drug has become "unfavourable." This will include a comprehensive system for monitoring the safety of approved drugs, as well as close cooperation with scientific bodies and pharmaceuticals producers.