Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries

• Published in: Revista panamericana de salud pública Vol. 45; no. 10; pp. e10 - 10
• Main Authors: Durán, Carlos E, Cañás, Martín, Urtasun, Martín A, Elseviers, Monique, Andia, Tatiana, Vander Stichele, Robert, Christiaens, Thierry
• Format: Journal Article
• Language: English
• Published: United States Pan American Health Organization (Organizacion Panamericana de la Salud) 01-01-2021; Organización Panamericana de la Salud; Pan American Health Organization
• Subjects: Authorization; caribbean region; drug approval; Drugs; government agencies; Health Policy & Services; Healthy food; Jurisdiction; latin america; Latin American cultural groups; Legislation; Marketing; Original Research; pan american health organization; pharmaceutical preparations; Regulation; Reliance; Teams; united states food and drug administration; Websites; Ecuador; Colombia; Argentina; Uruguay; United States > US; Paraguay; Costa Rica; El Salvador; Guatemala; Mexico; Australia; Chile; Peru; Pharmaceutical preparations; Pan American Health Organization; drug approval; United States Food and Drug Administration; Caribbean region; Latin America; government agencies; aprobación de drogas; Organización Panamericana de la Salud; órgãos governamentais; América Latina; Applicable regulation to approve new medicinal products via regulatory reliance in Latin America and the Caribbean; região do Caribe; Preparaciones farmacéuticas; región del Caribe; aprovação de drogas; agencias gubernamentales; Preparações farmacêuticas; Organização Pan-Americana da Saúde
• ISSN: 1020-4989; 1680-5348; 1680-5348
• DOI: 10.26633/RPSP.2021.10

To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on.
Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the
(trusted) regulators defined as such by the corresponding national legislation.
Regulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators.
Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.