Assessing New Medical Products in Health Emergencies: the EUAL Procedures - Norms and Standards. (WHO Drug Information Vol. 29, No. 3, 2015)
(2015; 19 pages)

Abrégé

Development and regulatory approval of medical products typically take many years. When an unprecedented Ebola outbreak devastated West African countries and kept on spreading, there were no approved vaccines, medicines or rapid diagnostic tests available to combat the disease. A WHO-convened ethical panel reached consensus that in this special situation, and provided certain conditions were met, it was ethical to use investigational products.

In the months that followed, WHO not only convened global players to accelerate R & D for Ebola, but also developed rules on how to identify those investigational products that can be used in an emergency – with the agreement of the competent regulatory authority – while they are being studied further. The Emergency Use Assessment and Listing (EUAL) procedures are the first of their kind of a global nature. They are a step ahead in ensuring that the world is prepared for future emergencies.

 
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