Washington, DC, 24 June 2019 (PAHO)- The Expert Committee for the Regulatory Landscape of the Americas met to discuss the scope and depth of a report that will landscape the industry and regulatory systems in the Americas.
Representatives from the Pan American Health Organization (PAHO), the US Food and Drug Administration (FDA), and National Regulatory Authorities (NRAs) from Argentina, Brazil, Chile, Colombia, and Cuba participated in this first Committee´s in-person meeting, which was held in Washington, DC, from 19-20 June 2019.
During the two-day meeting, attendees participated in different panel discussions that included the following topics: governance and organizational structure of regulatory authorities, authorizations, market surveillance, regulation and regional integration mechanisms (MERCOSUR, Pacific Alliance, Caribbean Community, and Central America), and preliminary data of the industry situation in Latin America.
The landscaping report will raise awareness and appreciation of the regulatory challenges NRAs face, increase understanding of national regulatory remits and capacity, and identify emerging markets and challenges.
Also, the report will provide a data-driven approach to understanding and improving regulatory capacity in the Americas. It will help to inform and identify opportunities, facilitate the implementation of PAHO/WHO resolutions and mandates, and provide a framework for strategic action by National Regulatory Authorities of Regional Reference (NRAr).
The Expert Committee was created in early 2019 by PAHO. It is composed of eight representatives of international organizations, government, industry, and academia, who are experts on data, economic, public health, regulatory systems, and industry trends analysis. The Committee will meet virtually as necessary, and in-person two times.
The project originated as a topic proposal from the NRAr in the Region and is part of a grant with the FDA, awarded by PAHO in late 2018, to conduct the landscape and issue a report on findings over the period of 18-months.