Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries/Utilizacion de decisiones de autoridades regulatorias de otras jurisdicciones para aprobar nuevos productos medicinales en paises de America Latina y el Caribe/Uso de decisoes regulatorias de outras jurisdicoes para aprovacao de novas especialidades farmaceuticas em paises da America Latina e Caribe

• Published in: Revista panamericana de salud pública 2021-01, Vol.45
• Main Authors: Duran, Carlos E, Canas, Martin, Stichele, Robert Vander, Urtasun, Martin A, Elseviers, Monique, Christiaens, Thierry, Andia, Tatiana
• Format: Article
• Language: English
• ISSN: 1020-4989
• DOI: 10.26633/RPSP.2021.10

Objective. 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. Methods. 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 reference (trusted) regulators defined as such by the corresponding national legislation. Results. 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. Conclusions. 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. Keywords Pharmaceutical preparations; government agencies; drug approval; United States Food and Drug Administration; Pan American Health Organization; Latin America; Caribbean region. Objetivo. Describir el estado actual de la utilizacion de las decisiones de autoridades regulatorias de otras jurisdicciones en America Latina y el Caribe mediante la evaluacion de los marcos regulatorios nacionales para la aprobacion de nuevos medicamentos y establecer los organismos regulatorios extranjeros que se consideran autoridades regulatorias confiables para cada pais. Metodos. Se realizaron busquedas en los sitios web de las