EMA ready to start assessment of Ebola vaccines and treatments as soon as data are made available
The European Medicines Agency (EMA) announced today in a press release that it was ready to start assessment of Ebola vaccines and treatments as soon as data were made available.
Over last several months the Agency has established a system that provides the best possible scientific advice to companies working currently on development of potential vaccines and/or treatments for fighting the Ebola virus. 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.
"We are ready and keen to assess data as soon as companies start submitting them,” explains EMA Executive Director Guido Rasi. "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.”
The March 2014 outbreak of Ebola virus disease in West Africa is the largest and most complex outbreak to date. It is unprecedented in terms of scale and geographical spread of the disease. At the moment, there are no approved medicines to protect from or treat Ebola. EMA is working together with regulatory authorities around the world to support the World Health Organization (WHO) in the fight against Ebola.
EMA’s role in the Ebola outbreak
Together with other regulatory authorities EMA is advising WHO on possible pathways for more rapid development, evaluation and approval of medicines to fight Ebola. This work aims at ensuring the consistency of different regulatory approaches.
A group of European experts with specialised knowledge in vaccines, infectious diseases and clinical trial design was established by the Agency to contribute to the global response against Ebola. This group is involved in the provision of rapid scientific advice and will also be responsible for the accelerated assessment of data generated by developers.
The EMA’s press release is entirely accessible on the EMA webpages or here.