EMEA expands responsibilities under new legislation
(EMEA) will be overhauled from 20 May to give it a stronger
advisory role to industry, the healthcare profession and patients.
Not least among the wide-ranging changes at the agency will be a change in name to the European Medicines Agency (although the acronym EMEA will still be used).
Elements of the new role include a reinforced role for the EMEA in the provision of scientific advice to companies, a cooperation with the World Health Organisation in giving opinions for the use of medicines outside the European Union, and opinions on the compassionate use of medicines -ahead of formal approval - in the EU member states.
A second wave of provisions come into effect in November 2005, including the use of conditional approvals for new products and fast-track reviews, a system akin to the priority review system in place in the US. This allows drugs for unmet medical needs to be approved on the basis of mid-stage clinical trial data, providing later-stage data is filed with the agency as it is generated.
The scope of the centralised approvals procedure - in which a single dossier can be used to gain approval across all 25 countries of the EU - will be extended.
In other changes, a new Committee for Medicinal Products for Human Use (CHMP) will replace the current Committee for Proprietary Medicinal Products (CPMP), and its membership will be changed from two to one member per EU state, with one additional member each from Iceland and Norway.
Additional information on the new structure of the EMEA can be downloaded here.
