Anvisa approves regulations for biosimilars
At a meeting of the Collegiate Board of Directors, Anvisa (the National Health Surveillance Agency) approved the new regulations for registering biosimilar medicines. The regulation dispenses with some specific steps and studies, when technically feasible, promoting a transparent and predictable regulatory environment for the sector.
If you need more information on regulatory issues in the pharmaceutical industry and healthcare, ELS can certainly help.
local ELS consultant or via email info@elssolutions.pt
ontact your