Skip to main content
Log in

Pharmacovigilance Regulatory Requirements in Latin America

  • Leading Article
  • Published:
Pharmaceutical Medicine Aims and scope Submit manuscript

Abstract

Latin American pharmacovigilance systems have developed considerably since the early 1990s and have continued to strengthen. The aim of this article is to review and analyse pharmacovigilance regulatory requirements governing the pharmaceutical industry’s activities in 21 countries in Latin America (Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Haiti, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Uruguay and Venezuela). For marketed pharmaceutical products, 16 countries have set up modalities of immediate reporting of adverse events (such as type of adverse event, report format, timelines and receivers) and only nine of them have implemented modalities for the periodic reporting of adverse events. Six countries have also established specific requirements for adverse events related to vaccines. Regarding clinical trials, ten countries have regulations for the immediate reporting of adverse events, and eight of them for periodic reporting.

When a country’s regulatory requirement level is compared with its Human Development Index (HDI), which integrates three basic dimensions of human development (i.e. health, education and standard of living), it appears that there is a correlation (2011 values): the mean of the HDI is 0.749 for high-level countries, 0.729 for medium-level countries and 0.604 for low-level countries. Most Latin American countries have high or medium levels of regulatory pharmacovigilance requirements, in line with international standards. Countries that have a low requirement level must still develop a pharmacovigilance system and appropriate regulatory measures, and they are strongly encouraged and supported by the WHO. The Subregional Pharmacovigilance Programmme and the Pan American Network for Drug Regulatory Harmonization also help the countries in Latin America to develop and harmonize pharmacovigilance regulations.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I
Table II
Table III
Table IV
Table V
Table VI

Similar content being viewed by others

References

  1. The importance of pharmacovigilance; safety monitoring of medicinal products. Geneva: World Health Organization, 2002 [online]. Available from URL: http://apps.who.int/medicinedocs/en/d/Js4893e/ [Accessed 2012 Mar 13]

  2. Pan American Health Organization. Red PARF Technical Document No. 5. Good pharmacovigilance practices for the Americas. 2010 Dec [online]. Available from URL: http://new.paho.org/hq/index.php?option=com_content&task=view&id=1592&Itemid=513&lang=en [Accessed 2011 Jun 28]

  3. Ministerio de Salud, Secretaría de Políticas, Regulación e Institutos, A.N.M.A.T. Guia de buenas praticas de farmacovigilancia [online]. Available from URL: http://www.anmat.gov.ar [Accessed 2011 Jun 28]

  4. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). ANMAT recuerda la vigencia de disposición 2438/00 y actualizaciones sobre informes al departamento de farmacovigilancia para: laboratorios de espescialidades medicinales habilitados por ANMAT [online]. Available from URL: http://www.anmat.gov.ar [Accessed 2011 Jun 28]

  5. Agência Nacional de Vigilância Sanitária (ANVISA). Resolução RDC n∘ 04, de 10 de fevereiro de 2009 [online]. Available from URL: http://portal.anvisa.gov.br/wps/portal/anvisa/posuso/farmacovigilancia [Accessed 2011 Jun 28]

  6. Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA). Resolución N∘ 2004009455 DEL 28 de mayo de 2004 [online]. Available from URL: http://web.invima.gov.co/portal/faces/index.jsp?id=2170 [Accessed 2011 Jun 28]

  7. Decreto N∘ 35244-S, Reglamento del Sistema Nacional de Farmacovigilancia, La Gaceta N∘ 98 — Viernes 22 de mayo del 2009/Pub. L. (2009) [online]. Available from URL: http://www.gaceta.go.cr [Accessed 2012 Mar 13]

  8. Centro para el Control Estatal de la Calidad de los Medicamentos, (CECMED). Regulación No. 51/08, Requisitos para la comunicación expedita y periódica de reacciones, eventos adversos, intoxicaciones, defectos de calidad y actividad fraudulenta a medicamentos durante la comercialización [online]. Available from URL: http://www.cecmed.sld.cu [Accessed 2011 Jun 28]

  9. Ministerio de Salud Pública y Asistencia Social Republica de Guatemala. Norma técnica 19-2009 Programa nacional de farmacovigilancia [online]. Available from URL: http://portal.mspas.gob.gt/index.php?option=com_content&view=article&id=282&Itemid=171 [Accessed 2011 Jun 28]

  10. Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). Norma Oficial Mexicana NOM-220-SSA1-2002, Instalación y operación de la farmacovigilancia [online]. Available from URL: http://www.cofepris.gob.mx [Accessed 2011 Jun 28]

  11. Ministerio de la Salud. Servicio Autonomo de Elaboraciones Farmaceuticas. Ley de medicamentos, Gaceta Oficial de la República Bolivariana de Venezuela N∘ 37.006 [online]. Available from URL: http://www.sefar.gob.ve [Accessed 2011 Jun 28]

  12. Normas de Buenas Praticas de Farmacovigilancia. Resolución N∘ 191 del 21 de Diciembre del 2002 200∘ y 151∘. Gaceta Oficial N∘ 39.579 del 22 de Diciembre del 2010 [online]. Available from URL: http://gaceta-oficial-venezuela.vlex.com.ve/source/gaceta-oficial-venezuela-1971/issue/2010/12/22/01 [Accessed 2012 Mar 13]

  13. Unidad de Medicamentosy Tecnologia en Salud (UNIMED). Ley del Medicamento N∘ 1737 de 17 de diciembre de 1996 [online]. Available from URL: http://www.sns.gob.bo. [Accessed 2011 Jun 29]

  14. Ministerio de Salud Pública y Asistencia Social. Decreto N∘ 246-06. que establece el reglamento que regula la fabricación, elaboración, control de la calidad, suministro, circulación, distribución, comercialización, información, publicidad importación, almacenamiento, dispensación, registro y donación de los medicamento [online]. Available from URL: http://www.sespas.gov.do [Accessed 2011 Jun 28]

  15. Ministerio de la Salud. Decreto Ejecutivo 178 de 12 de julio 2001. Que reglamenta la Ley 1 de 10 de enero de 2001 [online]. Available from URL: www.190.34.154.88 [Accessed 2011 Jun 28]

  16. Ministerio de la Salud, Dirección General de Medicamentos Insumos y Drogas (MINSA DIGEMID). Decreto Supremo N∘ 018-2001-SA [online]. Available from URL: http://www.digemid.minsa.gob.pe [Accessed 2011 Jun 28]

  17. Instituto de Salud Pública de Chile (ISP). Circular 09/2001, notificación voluntaria de reacciones adversas a medicamentos (RAM) [online]. Available from URL: www.ispch.cl/ctrl/resoluciones/PDF_2001/circular_09.pdf [Accessed 2011 Jun 28]

  18. Revista Judicial. Reglamento de registro sanitario para medicamentos en general, Registro Oficial 508,16-I-2009 [online]. Available from URL: http://www.derechoecuador.com [Accessed 2011 Jun 28]

  19. Ministerio de Salud Pública. Sistema Nacional de Farmacovigilancia [online]. Available from URL: http://www.msp.gub.uy [Accessed 2011 Jun 28]

  20. Centro de Estudios Judiciales. Ley N∘ 1119 de productos para la salud y otros, 1997 [online]. Available from URL: http://www.cej.org.py [Accessed 2011 Jun 28]

  21. Ministério da Saúde. Portaria conjunta N∘ 92,de 9 de outubro de 2008 [online]. Available from URL: http://bvsms.saude.gov.br/bvs/saudelegis/svs/2008/poc0092_09_10_2008.html [Accessed 2011 Aug 31]

  22. CECMED. Regulación No. 17/2008: directrices para la investigación de los eventos adversos supuestamente atribuibles a la vacunación o inmunización [online]. Available from URL: http://www.cecmed.sld.cu [Accessed on 2011 Jun 28]

  23. Ministerio de la Salud Pública y Asistencia Social. Initiativa N∘ 3641, Iniciativa de ley de vacunacion honorable pleno [online]. Available from URL: http://www.congreso.gob.gt [Accessed 2011 Jun 28]

  24. Pan American Health Organization. SANEVA-Red de países centinelas de eventos adversos de nuevas vacunas [online]. Available from URL: http://new.paho.org/hq/index2.php?option=com_content&do_pdf=1&id=1033/ [Accessed 2011 Jun 27]

  25. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). Disposición 6677/2010. Apruébase el Régimen de Buena Práctica Clínica para Estudios de Farmacología Clínica [online]. Available from URL: http://www.anmat.gov.ar [Accessed 2011 Jun 28]

  26. Unidad de Medicamentosy Tecnologia en Salud (UNIMED). Norma para estudios clínicos, Articulo 42h1 [online]. Available from URL: http://www.sns.gob.bo [Accessed 2011 Jun 28]

  27. Agência Nacional de Vigilância Sanitária. (ANVISA). Resolução-RDC n∘ 39, de 5 de junho de 2008 [online]. Available from URL: http://www.anvisa.gov.br [Accessed 2011 Jun 28]

  28. Instituto de Salud Pública de Chile. Circular 04, Aclara y actualiza los requisitos y condiciones de autorizaciones de uso de productos farmaceúticos sin registro sanitario para fines de investigación científica y sus modificaciones [online]. Available from URL: http://contacto.med.puc.cl/cei/docs/5_Leyes_Reglamentos_Nacionales/5e_Circular_N4_ISP.pdf [Accessed 2011 Jun 28]

  29. Instituto de Salud Pública de Chile. Norma Técnica n∘ 57. Regulación de la Ejecución de Ensayos Clínicos que Utilizan Productos farmacéuticos en Seres Humanos [online]. Available from URL: http://www.ispch.cl [Accessed 2011 Jun 28]

  30. Ministerio de la Proteccion Social. Resolución N∘ 2378 de 2008 [online]. Available from URL: http://200.13.243.186/Docencia/docs/Decreto2378de2008.pdf [Accessed 2011 Jun 28]

  31. Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED). Regulación 45-2007: requerimientos para la notificación y el reporte de eventos adversos graves e inesperados en los ensayos clínicos autorizados [online]. Available from URL: http://www.cecmed.sld.cu [Accessed 2011 Jun 28]

  32. Ministerio de la Salud Pública y Asistencia Social. Acuerdo Ministerial SP-M-466-2007 para la regulación de los ensayos clínicos en humanos [online] Available from URL: http://portal.mspas.gob.gt/index.php?option=com_content&view=article&id=283&Itemid=172 [Accessed 2011 Jun 28]

  33. Ministerio de la Salud, Dirección General de Medicamentos Insumos y Drogas (MINSA DIGEMID). Decreto Supremo N∘ 017-2006-SA, Aprueban el Reglamento de Ensayos Clínicos en el Perú [online]. Available from URL: http://www.digemid.minsa.gob.pe [Accessed 2011 Jun 28]

  34. Instituto Nacional de Higiene “Rafael Rangel”, Reglamento de Investigación en Farmacología Clínica, Normas de Junta Revisora de Productos Farmacéuticos. 2000 [online]. Available from URL: http://www.inhrr.gob.ve [Accessed 2011 Jun 28]

  35. United Nations Developement Programme (UNPD). Human development index and its components [online]. Available from URL: http://hdr.undp.org/en/statistics/ [Accessed 2012 Jan 2]

  36. Comision Tecnica Subregional de Medicamentos. Programa Subregionale de Farmacovigilancia. 2008 Oct 28 [online]. Available from URL: http://www.sicasalud.net [Accessed 2011 Jun 28]

  37. The Uppsala Monitoring Centre. To improve worldwide patient safety [online]. Available from URL: http://www.who-umc.org/ [Accessed 2012 Feb 22]

Download references

Acknowledgements

The views expressed are those of the authors. This review does not constitute formal regulatory guidance. The authors have no conflicts of interest that are directly relevant to the content of this review. No sources of funding were received for the preparation of this review.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Elise Hoffmann.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Hoffmann, E., Fouretier, A., Vergne, C. et al. Pharmacovigilance Regulatory Requirements in Latin America. Pharm Med 26, 153–164 (2012). https://doi.org/10.1007/BF03262389

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF03262389

Keywords

Navigation