Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
June 2016
http://www.paho.org/journal/

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Special Issue: Strengthening of Regulatory Systems for Medicines in the Americas
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.
[Series of articles]

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Strengthening of regulatory systems for medicines in the Americas
Etienne, Carissa F. Califf, Robert
Abstract
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 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 strong national regulatory system is, therefore, a critical component of a national health system. In this context, we are pleased to present the first ever special issue of the Pan American Journal of Public Health to focus on strengthening of regulatory systems for medicines and other technologies. This special issue is an expression of the resolve of the governments of the Americas in implementing the Pan American Health Organization Directing Council Resolution CD50.R9 (2010) “Strengthening National Regulatory Authorities for Medicines and Biologicals,” and more recently of the Member States of the World Health Organization in the adoption of resolution WHA67.20 (2014), “Regulatory system strengthening for medical products.”…The journal brings together articles from regulatory experts within the Region of the Americas as well as from global experts, who bring an array of experiences to the fore. They present the essential underpinning of science and regulation that bring life-saving and innovative products to the marketplace; analysis of key contributions from international fora and public-private coalitions that can add to regulatory science and the development of good regulatory practices; and the ever-evolving challenges that regulators face to build inter-linked and convergent regulatory systems within the context of limited capacity, human and financial resources, nationally and globally.