EMEA may participate directly in IMI

The European Medicines Agency (EMEA) has declared it may directly participate in pharmaceutical development project consortia under the EU Innovative Medicines Initiative (IMI).

In a communique, it announced: "The agency fully supports the overall goals of IMI, recognising its benefits for public health. We may therefore be willing and able to participate in select projects, contingent upon a number of considerations."

It would, however, avoid those projects that would require it to devote significant number of labour hours: "We need to be conscious of internal resource constraints," said EMEA.

It would also probably avoid projects involving potentially contentious technologies and development methods, because its panels might have to adjudicate later on their ethics and efficacy. These could involve "biomarkers, novel approaches to analysis of clinical trials, etc.," said EMEA, where it was "probable that some of these novel methodologies will..become part of a marketing authorisation dossier or a scientific advice procedure."