Health regulation is regarded as one of public health’s basic functions. Effective regulation of medicines promotes and protects the public’s health by guaranteeing medicines quality, safety, and efficacy; promoting the adequate manufacture, storage, and distribution of medicines; facilitating the fight against substandard, spurious, falsely-labeled, falsified, or counterfeit (SSFFC) medical products; providing the necessary information to health professionals and patients so they can use medicines rationally; and ensuring that access to medicines is not hindered by inefficient regulatory frameworks. Developing a national regulatory system is, hence, a critical component of a national health system.
This special issue of the Pan American Journal of Public Health was a joint project supported by the US Food and Drug Administration. The issue comprises 14 original peer reviewed research articles that highlight the progress and remaining challenges that the Region faces in ensuring access to safe, efficacious and quality-assured medical products.
Strengthening of regulatory systems for medicines in the Americas [Fortalecimiento de los sistemas regulatorios de los medicamentos en la Región de las Américas]
Carissa Etienne and Robert Califf
Editorial | Published 22 June 2016
Improving safety, quality and efficacy of medicines in the Americas [Mejora de la seguridad, calidad y eficacia de los medicamentos en la Región de las Américas]
Ricardo Bolaños, Katherine Bond, Raquel Child, José Vicente Coto, Rudolph Cummings, Nora Dellepiane, James Fitzgerald, Cathy Parker, Patricia Pereira, Julio Sánchez y Tépoz and Andy Stergachis
Editorial | Published 22 June 2016
Regulatory convergence and harmonization: barriers to effective use and adoption of common standards [La convergencia y la armonización regulatorias: barreras en el uso y la adopción eficaces de normas comunes]
María Luz Pombo, Analía Porrás, Patricia Claudia Saidon, Stephanie M. Cascio
Original Research | Published 22 June 2016
A regulação sanitária brasileira como parte da política de saúde: lacunas e desafíos [Sanitary regulation as part of health policy in Brazil: gaps and challenges]
Christiane Maia e Dirce Guilhem
Original Research | Published 22 June 2016
Centro regulador de medicamentos de la Alianza Bolivariana de Nuestros Pueblos de América (ALBAMED): nueva iniciativa de integración reguladora [Regulatory Center for Medicines of the Bolivarian Alliance for the Peoples of the Americas (ALBAMED): a new initiative for regulatory integration]
Celeste Aurora Sánchez González
Original Research | Published 22 June 2016
Situación de la regulación de los dispositivos médicos en la Región de las Américas [Regulation of medical devices in the Region of the Americas]
Nilda Enríquez, Yadira Álvarez, Dulce María Martínez, Ana Pérez y Alexandre Lemgruber
Original Research | Published 22 June 2016
Sharing regulatory data as tools for strengthening health systems in the Region of the Americas [El intercambio de datos sobre reglamentación para fortalecer los sistemas de salud en la Región de las Américas]
Varley Dias Sousa, Pedro I. Ramalho, and Dâmaris Silveira
Special Report | Published 22 June 2016
Fortalecimiento de la Red Panamericana de Laboratorios Oficiales de Control de Medicamentos [Strengthening the Pan American Network of Official Medicines Control Laboratories]
José María Parisi, Damián Cairatti, y José Luis Castro
Special Report | Published 22 June 2016
Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states [La regionalización como medio para fortalecer los sistemas de reglamentación: estudio de caso en los estadosmiembros del CARICOM]
Charles Preston, Harinder S. Chahal, Analia Porrás, Lucette Cargill, Maryam Hinds, Babatunde Olowokure, Rudolph Cummings, and James Hospedales
Special Report | Published 22 June 2016
Cooperación Sur-Sur para el fortalecimiento de los laboratorios de control de medicamentos de la Comunidad del Caribe (CARICOM) [South-South cooperation to strengthen the medicines control laboratorios of the Caribbean community (CARICOM)]
José María Parisi, José Luis Castro, María Celina Luque, Marta Spinetto, Patricia Saidón, Raquel Méndez, y James Fitzgerald
Special Report | Published 22 June 2016
Propuesta de un modelo de gestión de medicamentos en indicaciones no registradas en Colombia [Proposed model for managing drugs used for unregistered indications in Colombia]
Egdda Patricia Vanegas, Ángela Patricia Acosta, Claudia Patricia Vaca González, José Julián López Gutiérrez, Laura Angélica Pineda, Javier Humberto Guzmán, Alejandro Gaviria y Fernando Ruiz
Special Report | Published 22 June 2016
Iniciativas de convergência regulatória em saúde nas Américas: histórico, evolução e novos desafios [Convergence of healthcare regulation in the Americas: history, development, and new challenges]
Ana Paula Jucá Silva e Patrícia Oliveira Pereira Tagliari
Special Report | Published 22 June 2016
Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas [Cincuenta años de la red europea de reglamentación farmacéutica: reflexiones en torno al fortalecimiento de la cooperación intrarregional en la Región de las Américas]
Martin Harvey Allchurch, Dirceu Brás Aparecido Barbano, Marie-Hélène Pinheiro, and Janis Lazdin-Helds
Special Report | Published 22 June 2016
Fortalecimiento de la regulación sanitaria en las Américas: las autoridades reguladoras de referencia regional [Strengthening health regulation in the Americas: regulatory authorities of regional reference]
Lisette Pérez Ojeda y Rafael Pérez Cristiá
Special Report | Published 22 June 2016
Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings [Establecimiento de un modelo de cadena de valor reglamentaria: un enfoque innovador para fortalecer los sistemas de reglamentación farmacéutica en entornos de escasos recursos]
Harinder Singh Chahal, Farrah Kashfipour, Matt Susko, Neelam Sekhri Feachem, and Colin Boyle
Special Report | Published 22 June 2016
Experiencias y desafíos actuales para el Programa Regulador de Equipos Médicos en Cuba [Regulatory Program for Medical Devices in Cuba: experiences and current challenges]
Dulce María Martínez Pereira, Yadira Álvarez Rodríguez, Yamila Cedeño Valdés, y Silvia Delgado Ribas
Opinion and Analysis | Published 22 June 2016
The Pan American Journal of Public Health recognizes with appreciation the contributions of the members of the Editorial Committee:
Ricardo Bolaños, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Argentina; Katherine Bond, United States Pharmacopeia, United States (formerly with the US Food and Drug Administration (FDA), United States); Raquel Child, Ministerio de Salud, Chile; José Vicente Coto, Dirección Nacional de Medicamentos, El Salvador; Rudolph Cummings, Caribbean Community (CARICOM), Guyana; Nora Dellepiane, World Health Organization (WHO); James Fitzgerald, Pan American Health Organization (PAHO/WHO); Cathy Parker, Health Canada, Canada; Julio Sánchez y Tépoz, Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), México; Patricia Pereira, Agência Nacional de Vigilância Sanitária (ANVISA), Brasil; Andy Stergachis, University of Washington, United States
Their contributions and dedication to this special issue were extraordinary, and helped make the manuscripts more interesting, more accurate, and more useful to our readers and all others who work to improve the health of the peoples of the Americas.
The Journal would like to give special thanks to the U.S. Food and Drug Administration, whose financial and programmatic contributions were essential to the publication of this special issue.