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Monday, August 14, 2017 10:08:43 AM
Appropriately, the focus on Anavex drug approvals centers on the USA and the Food and Drug Administration (FDA).
But there is no universal drug approval agency. Each country or union has its own procedures and schedules, varying markedly from the FDA.
Just read an article on this, telling how improved drug approval protocols will be speedy and more cost effective
"...The results show that international pharmaceutical companies encounter very different regional requirements.
Depending on the country, identical products are being evaluated not only according to different standards and processes to verify their effectiveness and safety, but certain aspects are also being reviewed and assessed multiple times and in various ways.
The regulatory hurdles for approval (fees, studies, evaluation periods, etc.) are known to be a significant time factor in the global drug development. Different approval requirements prolong the time until the market entry of new, innovative drugs which also impacts their price. The study thus shows that a harmonization of these approval requirements and processes could significantly improve efficiency.
"Patients would profit especially since new drugs would be available faster and at lower prices," comments Prof. Dr. Thomas D. Szucs from the European Center of Pharmaceutical Medicine at the University of Basel. "This suggests that companies and authorities should strengthen their international collaboration and communicate better with each other."
With their study, the researchers hope to contribute to higher cost efficiency in the development of drugs and shorter authorization processes.
https://www.eurekalert.org/pub_releases/2017-08/uob-dan081417.php
Might Anavex 2-73 first be approved and used elsewhere, perhaps first in Australia, then in several other countries? The Alzheimer's epidemic is global, with monstrous, elevating costs in every country as the WWII boomer populations head into their 70s.
As with all Anavex topics, one must think big; and now, broad, across the entire world.
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