Improving safety, quality and efficacy of medicines in the Americas

Abstract

In the Region of the Americas, access to medicines and other health technologies constitutes a priority for countries as they continue to move towards universal access to health and universal health coverage. Ensuring the availability of affordable medicines and health technologies within health services is required as part of the comprehensive approach to disease prevention and control. Through the adoption of pharmaceutical policies and strategies at the national level, governments establish the framework that will ensure equitable access and affordability of medicines and health technologies, while promoting their rational use. Core to such policies and strategies is the principle of quality, safety and efficacy. The pharmaceutical and health technology sector plays a critical role in the health promotion and protection by ensuring that those products and technologies made available through the health systems respond to international norms of quality and safety. The role of the government, and in particular the ministry of health, jointly with interested stakeholders, is to create a regulatory environment that guarantees the quality of the product throughout its life cycle, to ensure patient safety and optimize health outcomes. As globalization continues, with an ever increasing flow of people and products across borders, product quality and safety becomes a co-responsibility between countries and interconnected regulatory systems—nationally, regionally and globally. The regulatory landscape for medicines and health technologies is complex, given the multiple different types of product (medicines, biologicals, medical devices, etc.), the co-existing of single, limited and multiple source products within the market, the increasing technological complexity of new products entering the market (genomic, biotechnical products, etc.), and the critical array of regulatory functions (clinical studies, manufacturing, distribution, post marketing surveillance, etc.)...