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

Autor:	Durán CE; Ghent University Ghent Belgium Ghent University, Ghent, Belgium., Cañás M; Federación Médica de la Provincia de Buenos Aires (FEMEBA) La Plata Argentina Federación Médica de la Provincia de Buenos Aires (FEMEBA), La Plata, Argentina., Urtasun MA; Federación Médica de la Provincia de Buenos Aires (FEMEBA) La Plata Argentina Federación Médica de la Provincia de Buenos Aires (FEMEBA), La Plata, Argentina., Elseviers M; Ghent University Ghent Belgium Ghent University, Ghent, Belgium., Andia T; Universidad de los Andes Bogotá Colombia Universidad de los Andes, Bogotá, Colombia., Vander Stichele R; Ghent University Ghent Belgium Ghent University, Ghent, Belgium., Christiaens T; Ghent University Ghent Belgium Ghent University, Ghent, Belgium.
Jazyk:	angličtina
Zdroj:	Revista panamericana de salud publica = Pan American journal of public health [Rev Panam Salud Publica] 2021 Apr 09; Vol. 45, pp. e10. Date of Electronic Publication: 2021 Apr 09 (Print Publication: 2021).
DOI:	10.26633/RPSP.2021.10
Abstrakt:	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.
Databáze:	MEDLINE
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