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US FDA looks to increase cooperation with Latin American counterparts

By Zachary Brennan+

21-Jul-2014
Last updated on 21-Jul-2014 at 10:06 GMT

Pan American Health Organisation building in Washington DC, US
Pan American Health Organisation building in Washington DC, US

The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).

Beginning in September 2010 , the FDA and PAHO are currently involved in a four-year cooperative agreement an electronic platform to exchange regulatory information, which is called the Regional Platform for Access and Innovation of Health Technologies (PRAIS).

PRAIS includes features such as communities of practice, where regulators can share information and engage in real-time dialogue around regulatory issues, and an “observatory,” where information on the basic structures and functions of participating regulatory authorities is housed.

The cooperative agreement announced in a recent Federal Register notice will expand the collaborations between FDA and PAHO to support more data-driven and science-based public health strategies and approaches. The objective is to strengthen regulatory capacity throughout the Americas.

The extended partnership will further enable the sharing of scientific findings and data through expert meetings and technical consultations; assist member states in the implementation and subsequent evaluation of internationally-recognized standards and guidelines, e.g. WHO guidelines and ICH standards; and help to facilitate the alignment and convergence of standards between PAHO, other regions, and other global regulators.

The FDA lays out three goals for the potential collaboration: to develop and apply regional and global norms and standards, research regulatory systems performance and understand further the current state of medical product regulation, and provide technical support to regulatory systems.

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