Regulatory News

EMA to Cut One Drug Division, Strengthen Collaborations With National Competent Authorities

As the European Medicine Agency (EMA) prepares to relocate its headquarters from London, thanks to the Brexit vote, the agency is also restructuring as part of what it says will be a leaner, more streamlined architecture that builds on the overhaul from 2013 and 2014.

The EMA said on Friday that as part of this fine-tuning process, beginning 1 September 2016, the agency will have one less division dealing with human medicines, a newly dedicated focus on strengthening collaborations with member state competent authorities and a further streamlining of its division dealing with administration and corporate planning.

EMA Executive Director Guido Rasi said in a statement: “We want to do more with the resources we have by designing the Agency’s structures and processes around the lifespan of medicines.” He also noted that the fine-tuning is part of progress made over the past two years.

Main changes include:

• Cutting one division dealing with human medicines (ie. Going from four to three, with one division responsible for support to medicines developers, one for the evaluation of medicines bringing scientific and procedure management under one umbrella, and one for the oversight of medicines, including pharmacovigilance and inspections)
• Creating a new function dedicated to strengthening the collaboration between EMA and national competent authorities by overseeing the implementation of a joint network strategy to 2020, promoting innovation in regulatory science across the EU and addressing the increasing complexity of its committees’ coordination of activities
• “Streamlining the division dealing with administration and corporate management through separate entities for strategic planning, budgeting and monitoring, finance and procurement, and support to staff and delegates”

The EMA also added that interactions between stakeholders and the agency will not be affected by these changes.

Organizational Chart for 1 September 2016