EMA moves further to push Ebola treatments development

During the past months, the European Medicines Agency has put in place a system to give the best possible scientific advice to companies that are currently developing possible vaccines and/or treatments to fight Ebola virus disease. This goes along side with the Agency urging companies with  potential Ebola candidates to seek orphan designation to help speed approval of their products.

The Agency has also established a form of rolling review that allows experts to continuously assess incoming data and develop increasingly robust scientific opinions based on the additional data provided during the process. The initial review and subsequent updates will be shared with healthcare decision-makers in the most affected and other countries. This will enable them to take informed decisions on whether and how they want to use the vaccines/medicines in the current Ebola outbreak taking into account their specific situation.

“We are ready and keen to assess data as soon as companies start submitting them,” said EMA executive director Guido Rasi, adding: “We have put in place regulatory processes that allow the best experts from across Europe to accelerate the assessment of data once we receive them.”