EMA Has Implemented Changes to its Organisational Structure

05 March 2020

GMP News

The purpose of the re-organisation is to ensure that the Agency operates as efficiently as possible to deliver high quality outputs for public and animal health. The exercise takes into account the rapidly evolving landscape for pharmaceutical research and development that requires regulators to keep up with advances in science and technology and prepare for future challenges at an ever-accelerating pace.

The change is also driven by the need to recalibrate to a lower head count following the relocation of the Agency to Amsterdam in 2019 whilst dealing with an increased workload due the implementation of various new pieces of legislation.

“These organisational changes will strengthen our ability to carry out important new activities together with our partners in the European medicines regulatory network and tackle the important opportunities and challenges that lie ahead, such as analysis of healthcare data, digitalisation and new scientific methods and technologies,” said EMA’s Executive Director Guido Rasi. “It will also ensure that we are geared up for the future with more efficient processes firmly rooted in data and digital technology to keep pace with rapid advances in science.”

The main, high-level changes are as follows:

Operations in the area of human medicines have been integrated into one Human Medicines Division, which will be led by Alexis Nolte. The structure of the Veterinary Medicines Division, under the leadership of Ivo Claassen, remains unchanged.

In addition, four mission-critical task forces have been established to support the human and veterinary medicines divisions, bringing together expertise to drive transformational change in the following high-priority areas:

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