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Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas

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Date
2016-05
Author
Allchurch, Martin Harvey
Barbano, Dirceu Brás Aparecido
Pinheiro, Marie-Hélène
Lazdin-Helds, Janis
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Abstract
This report considers how the experience of the European regulatory system might be applied to help strengthen the regulatory systems for medicines in the Region of the Americas. The work of the European Medicines Agencies (EMA) is carried out through its scientific committees, composed of members from European Economic Area countries. A robust legal framework allows EMA to coordinate resources from Member States’ competent authorities, including, for example, assisting candidate countries as they prepare to join the European Union (EU). Capacity-building programs help countries adjust their regulatory systems ahead of full participation in the European medicines regulatory network. These programs facilitate adoption of common technical requirements, identify areas where action might be needed to ensure the smooth transposition of EU pharmaceutical law into national legislation, and prepare candidate countries for participation in EMA committees and the European regulatory network. The methodology of these programs could be of potential interest to the Pan American Health Organization (PAHO), the Regional Office of the World Health Organization for the Americas. Given resolutions adopted by the World Health Assembly and the PAHO Directing Council, there is a strong indication that the countries of the Region of the Americas wish to assemble a system that uses the existing regulatory capacity of some countries to strengthen local regulatory capacities in others.
 
En el presente informe se examina la forma en que podría aprovecharse la experiencia del sistema reglamentario europeo para ayudar a fortalecer los sistemas de reglamentación farmacéutica de la Región de las Américas. Las agencias europeas de medicamentos (EMA) llevan a cabo su labor por conducto de sus comités científicos, que están integrados por miembros de los países del Espacio Económico Europeo. Un marco jurídico sólido les permite a estos organismos coordinar los recursos de las autoridades competentes en los Estados Miembros para fines como, por ejemplo, ayudar a países candidatos a prepararse para ingresar en la Unión Europea (UE). Los programas de fortalecimiento de la capacidad ayudan a los países a ajustar sus sistemas de reglamentación antes de empezar a participar de lleno en la red europea de reglamentación farmacéutica. Estos programas facilitan la adopción de requisitos técnicos comunes, determinan las áreas en que podrían hacer falta medidas para lograr la transposición eficaz de las leyes farmacéuticas de la UE en leyes nacionales, y preparan a los países candidatos para su participación en los comités de las agencias europeas de medicamentos y en la red de reglamentación europea. Los métodos aplicados en estos programas podrían ser de interés para la Organización Panamericana de la Salud (OPS), que es la Oficina Regional de la Organización Mundial de la Salud (OMS) para las Américas. Dadas las resoluciones adoptadas por la Asamblea Mundial de la Salud y el Consejo Directivo de la OPS, hay claros indicios de que los países de la Región de las Américas aspiran a crear un sistema en el que se utilice la actual capacidad reglamentaria de determinados países para fortalecer la capacidad reglamentaria local en otros.
 
Translated title
Cincuenta años de la red europea de reglamentación farmacéutica: reflexiones en torno al fortalecimiento de la cooperación intrarregional en la Región de las Américas
Series
Rev Panam Salud Publica;39(5), mayo 2016
Subject
Legislation, Drug; Drug Approval; Drug and Narcotic Control; Health Care Coordination and Monitoring; Health Surveillance; European Union; Americas; Legislación de Medicamentos; Aprobación de Drogas; Regulación y Fiscalización en Salud; Control de Medicamentos y Narcóticos; Vigilancia Sanitaria; Unión Europea
URI
https://iris.paho.org/handle/10665.2/28522
Citation
Harvey Allchurch M, Barbano DBA, Pinheiro MH, Lazdin-Helds J. Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas. Rev Panam Salud Publica. 2016; 39(5):288–93.
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