Will Europe’s Regulatory Reorg Slow – or Speed – New Therapies to Patients?

by Amanda Conschafter, blog editor

The European Medicines Agency’s 18-month organizational overhaul is nearly complete. But stakeholder enthusiasm for the changes proves lackluster, according to Scrip Regulatory Affairs – despite adjustments meant to improve the regulatory process. The EMA asks for patience during its transition period. Yet stakeholders’ complaints raise questions about how the reorganized EMA will handle increasingly complex regulatory requirements – and how structural changes will affect patient access to new medical therapies.

Restructuring focused on several key areas, including medicine evaluation and pharmacovigilance. In addition to reconfiguring units and divisions, the EMA introduced positions for new staff to streamline regulatory processes. Procedure managers, for example, now function as industry’s primary point of contact for new medicines. They guide representatives step by step through the application process. The EMA also introduced product leads, who oversee a product throughout its lifecycle. Product leads possess knowledge of both the product and its therapeutic area.

Despite the EMA’s goal to “better meet the needs of its stakeholders” through these changes, stakeholders have voiced repeated complaints. During the EMA Review of the Year and Outlook for 2015 Meeting, industry representatives described a lack of internal coordination, inconsistency among the scientific opinions provided by EMA staff, rocky staff transitions and flawed electronic communication systems.

The fate of EMA’s restructuring could have far-reaching effects. For instance, more knowledgeable staff to streamline an arduous application process could encourage research and investment in new therapies. Patients, in turn, could have faster access to breakthrough medicines – with the added assurance of consistent, effective safety monitoring throughout the therapies’ lifecycle. With these benefits in mind, EMA representatives request patience during the transition’s “settling-in” period.

Meanwhile, patient access to increasingly sophisticated pharmaceutical and biopharmaceutical advances demands efficient, effective regulatory capabilities. Thus, stakeholders wait to see how a restructured EMA will fare in assessing, approving and monitoring the next generation of medical therapies.

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