Brexit - EMA suspends clinical data publication
As a consequence of Brexit, the European Medicines Agency ("EMA") will relocate its headquarters to Amsterdam by March 2019. It is now clear that the agency will lose significantly more staff than first anticipated. Staff who will not relocate to Amsterdam have already started to leave the Agency and this tendency is only expected to increase. Therefore, EMA has announced that it has to prioritize its resources and will, inter alia, temporarily suspend clinical data publication.
This is evident from EMA's recently published Phase 3 in the so-called Brexit Preparedness Business Continuity Plan. In order to safeguard its core activities related to the evaluation and supervision of medicine EMA has to temporarily scale back and in some cases entirely suspend less essential activities until 2019.
One of the activities which, temporarily, will be suspended entirely is the publication of clinical data. The clinical data sent from the industry to EMA after August 1st 2018 in order to obtain approval of medicines will therefore not be published for the time being.
The announcement comes shortly after EMA on July 16th 2018 published a report on its transparency policy (0070), which entered into force in January 2015.
Through the implementation of the transparency policy EMA has, as the first medicines regulatory authority in the world, since October 20th 2016, as a rule published all clinical data submitted by pharmaceutical companies in support of marketing authorisation applications.
The report can be read here
The other activities affected by the scale backs due to Brexit can be found in EMA's announcement regarding the so-called Brexit Preparedness Business Continuity Plan linked directly below.
The announcement can be read here