European Medicines Agency (EMA) launch new ESEC for NAMs

The European Medicines Agency (EMA) have launched their third European Specialized Expert Community (ESEC). It is expected to be fully up and running by the end of 2023 and will support the regulatory acceptance of alternatives to traditional animal models in drug development and testing. The mandate (published in March 2023) can be found here.

The group is intended to provide a “platform for information sharing and communication on scientific and regulatory topics related to the non-clinical field, including the rapidly advancing area of NAMs”, the EMA have said. It noted, however, that there are certain membership restrictions in place.

One of the main purposes of the Non-Clinical and NAMs ESEC will be to facilitate the regulatory acceptance of these new methodologies and support the EMA in delivering its non-clinical domain workplan.

The EMA has also established ESECs in oncology and hematology. It said that these expert communities “fill a gap,” because the agency’s working parties and committees are limited in terms of their membership numbers and the pool of people eligible to join, whereas ESECs are “less restricted.”