Regulation of the registration of biological drugs in Latin America

Biosimilars/Research | Posted 19/11/2021 post-comment0 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 to view the following manuscript published in GaBI Journal:

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

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.

Readers interested in contributing a research or perspective paper in Spanish and/or English to GaBI Journal – an independent, peer reviewed academic journal – please submit your manuscript here.

GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
2.1 – CiteScoreTracker 2021 (Last updated on 4 November 2021)

Submit a manuscript to GaBI Journal

Related articles
Progress in the regulation of biosimilars in the EU 

Collaboration between regulatory authorities for biosimilars

Regulatory issues related to quality of biosimilars

Regulatory challenges with biosimilars


The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View last week’s headline article: Regulación del registro de medicamentos biológicos en América Latina

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.


Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de la semana pasada: Regulación del registro de medicamentos biológicos en América Latina

Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


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.

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010