PAHO/WHO-led cooperation on drug regulatory systems is showcased at Global South-South Development Expo

21 Nov 2014
PAHO/WHO-led cooperation on drug regulatory systems is showcased at Global South-South Development Expo

Global South South Expo

A country-to-country cooperation initiative aimed at strengthening drug regulatory systems in Latin America and the Caribbean was presented at the Global South-South Development Expo in Washington, D.C., this week as a model South-South cooperation effort.

Washington, D.C., 21November 2014 (PAHO/WHO) — A country-to-country cooperation initiative aimed at strengthening drug regulatory systems in Latin America and the Caribbean was presented at the Global South-South Development Expo in Washington, D.C., this week as a model South-South cooperation effort.

The initiative, "Development of Drug Regulatory Systems in the Americas," is coordinated by the Pan American Health Organization/World Health Organization (PAHO/WHO) in cooperation with its member countries in Latin America and the Caribbean. It is one of many South-South cooperation efforts PAHO/WHO has supported as part of it technical cooperation with member countries in the Americas.

"The Region of the Americas has demonstrated over time that it is committed to South-South and triangular cooperation in keeping with global solidarity and the more-than-a-century-old tradition of Pan Americanism," said PAHO Deputy Director Isabella Danel at the close of the week-long Expo. "Ours has been a very vibrant region in promoting and exporting solutions in health."

The Development of Drug Regulatory Systems in the Americas has established a network of drug regulatory agencies in PAHO/WHO member countries to enable them to share experiences, expertise, standards and procedures to strengthen their ability to ensure the safety, effectiveness and accessibility of medicines and medical technologies for their populations. The effort has grown significantly over the past decade and now includes shared inspection reports and shared approvals of pharmaceutical products and medical devices.

Having a strong drug regulatory system is essential for countries, and PAHO/WHO has been working with countries since 2000 to build capacity in this area through country-to-country cooperation and through the identification and assessment of regulatory functions, which range from licensing of drug manufacturers and approval of new medical products to combatting counterfeit drugs.

As part of this initiative, PAHO/WHO and the countries have established the Pan American Network for Drug Regulatory Harmonization (PANDRH), the Pan American Network of Official Medicines Control Laboratories, a Regional Pharmacovigilance Network, and the Regional Network of National Laboratories for Quality Control of Vaccines.

In addition, the drug regulatory agencies of seven countries (Argentina, Brazil, Canada, Colombia, Cuba, Mexico and the United States) have been designated as National Regulatory Authorities of Regional Reference, serving as models and sharing expertise for the development of stronger regulatory capacity in other countries.

The "Development of Drug Regulatory Systems in the Americas" initiative was presented at the South-South Development Expo by David Baca Grande of Mexico's Federal Commission for the Protection against Sanitary Risk (COFEPRIS), one of the seven National Regulatory Authorities of Regional Reference. Currently, six other countries (Chile, Colombia, Costa Rica, Ecuador, El Salvador, and Panama) are negotiating agreements and developing national regulations to allow them to recognize and apply COFEPRIS's product registrations in their domestic markets.

Other achievements of this South-South cooperation initiative include the establishment of a Caribbean Regulatory System for CARICOM member states, which will be supported by the U.S. Food and Drug Administration (FDA) and Argentina; and discussions toward the creation of a Regional Center and Single Registry for Medicines for member countries of the Bolivarian Alliance for the Peoples of Our America (ALBA).

In addition to PAHO/WHO, other partners supporting this work include the World Bank and the Bill and Melinda Gates Foundation.

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