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FDA to Spend up to $10 Million Strengthening Regulation in South America

Posted 17 July 2014

FDA to Spend up to $10 Million Strengthening Regulation in South America

US regulators are planning to work more closely with a global health group focused heavily on South America in the hopes of strengthening medical product regulatory systems across the region.

In an announcement on 8 July 2013, the US Food and Drug Administration (FDA) said it plans to award the Pan American Health Organization (PAHO) a contract to help "foster regulatory collaboration and strengthen regulatory capacity throughout the Americas."

Regulatory capacity broadly refers to the ability of a regulatory system to regulate, and includes factors like monetary resources, staff expertise and authority.

The broader hope is that by helping out global regulators, FDA can actually better protect US consumers.

"These activities help to strengthen regulatory systems which, in this era of globalization, where the supply chain of medicines has become a global network, and as national, regional, and global health programs work to scale up access to medicines and health products, strong regulatory systems are imperative," FDA wrote.

In other words, if regional or local regulators can stamp out illicit or sub-standard products prior to their export, US consumers may never be exposed to them. Similarly, if other regulators notice problems with a drug, that information may be of use to US officials as well.

FDA says it wants PAHO to focus on helping to develop South American regulatory systems, with a particular focus on the core competencies of those systems.

PAHO is prepared to do this, FDA said, by "disseminating quality norms and standards, facilitating the exchange of regulatory information, evaluating regulatory authorities, providing training and technical assistance, distributing scientific materials and information on aspects of regulation, strengthening regional monitoring and surveillance for falsified and substandard products, and building capacity as a component of WHO's prequalification programs."

The five-year agreement is worth up to $10 million, FDA said, or $2 million per year.


Federal Register Announcement


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