EFPIA Report Pinpoints Risks From EMA Relocation


Applied Clinical Trials

A new 25-page report commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA) has highlighted the serious risks posed to public health by the relocation of the European Medicines Agency (EMA). The relocation will restrict the agency’s ability to call on and manage the network of expertise it relies on and limit staff retention and capacity, warns the authors.

Compiled by the consulting firm Charles Rivers Associates, the study analyzes the range of activities undertaken by the EMA and considers the impact of the move on continuity, patients, and approval of new medicines.

The report identifies two key areas-the evaluation of applications for marketing authorization and monitoring the safety of medicines across their lifecycle-as having the most significant detrimental effect on public health due to the relocation.

Delays in evaluating applications for marketing authorization mean delays in access to new medicines for patients across Europe, while disruption to critical safety functions can lead to delays in identification, management, and communication of safety issues, thereby putting patients at risk, according to the authors.

Transitional arrangements must be put in place to ensure the EMA has the time to manage the relocation and safeguard public health, they stated.

"The EMA plays a key role in Europe's health, ensuring that medicines are safe, effective, and of high quality,” noted EFPIA Director General Nathalie Moll. “This report underlines the importance of both the location decision and transitional arrangements to the agency's future. Supporting the continuity of its critical functions, its ability to retain staff, and access expert networks is central to its future and to public health."

To download a copy of the report, click here.

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