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Regulation of the registration of biological drugs in Latin America

Biosimilars/Research | Posted 19/11/2021 0 Post your comment

Biological drugs are defined as products with active ingredients produced from a biological source, whereas a biotechnological product is developed from the isolation of a gene of interest and its cloning [1].

The development of biological and biotechnological products in Latin America is remarkably diverse due to the particularities related to numerous factors such as cultural, economic, political, and regulatory factors. Each Latin American country therefore has a unique market and regulatory outlook.

The study conducted by Ramírez-Telles et al. published in 2021 made a comparative study to determine the differences in the current regulations regarding biological and biotechnological drugs in nine countries of Central America and the Caribbean that currently have a regulatory framework for their registration. It included Costa Rica, Guatemala, El Salvador, Honduras, Panama, Cuba and the Dominican Republic. Brazil and Chile, considered, among others, as the regulatory authorities of regional reference level IV of the Pan American Health Organization (PAHO), were used as parameters for comparison.

Table 1 below shows each of the regulations reviewed in each of the countries studied.

Table 1: Regulation for the registration of biological and biotechnological drugs effective as of July 2020 in Latin American countries

Country	National Regulatory Authority (NRA)	Current regulation	Year
Brazil	Agencia Nacional de Vigilancia Sanitaria (ANVISA)	RDC 55/2010: dispõe sobre o registro de produtos biológicos novos e produtos biológicos e dá outras providências	2010
Chile	Instituto de Salud Pública de Chile (ISP)	Registro sanitario de productos biotecnológicos derivados de técnicas ADN recombinantes (Norma Técnica nº170)	2018
Cuba	Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)	Requisitos Para el Registro Sanitario de Productos Biológicos de Uso Humano (Regulación M 83-15)	2015
El Salvador	Dirección Nacional de Medicamentos de El Salvador (DNM)	Guía para el registro de medicamentos biológicos y biotecnológicos	2017
Guatemala	Ministerio de Salud Pública y Asistencia Social	Registro Sanitario de Referencia para Productos Biológicos y Biotecnológicos (Norma Técnica 67-2019)	2019
Honduras	Agencia de Regulación Sanitaria de Honduras (ARSA)	Comunicado C-003-ARSA-2018. Provisions to obtain a Sanitary Registration of Natural Supplements, Galenic Products, Homeopathic Products, Radiopharmaceuticals, Biological Products and Biotechnological Products	2018
Panamá	Dirección Nacional de Farmacia y Drogas	Decreto Ejecutivo N°95 (14 de mayo de 2019) Gaceta oficial Gobierno de la República de Panamá, Ministerio de Sanidad	2019
República Dominicana	Ministerio de Salud Pública y Asistencia Social: Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS)	Reglamento Técnico para el Registro Sanitario de Medicamentos Biotecnológicos Innovadores y No Innovadores para Uso Humano en la República Dominicana (Resolución 000018)	2016
ANVISA, CECMED and ISP are regulatory authorities of regional reference level IV of PAHO.

The following series of four articles provides a more detailed analysis of the comparative study of the regulations related to biological and biotechnological products in Central American and Caribbean countries with respect to those of Chile and Brazil. This made it possible to know the positions established in each of the countries with respect to the marketing of these drugs.

Editor’s comment
Readers interested to learn more about biosimilar regulation implementation in Latin America are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Recommendations for the regulation of biosimilars and their implementation in Latin America

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Reference
1. Ramirez-Telles M, Mora-Roman Jose J, Fallas-Cartin M. Registro sanitario de medicamentos biológicos y biotecnológicos en América Latina. Ars Pharm. 2021;62(2):131-43.

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