Latin American pharmaceutical overview

J. Valverde
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引用次数: 5

Abstract

Latin America is a diverse, multi-coloured and dynamic region; boast the highest life expectancy among developing regions. In Latin America persistent social exclusion and inequities in wealth distribution and in access and use of services are reflected in health outcomes. With its population reaching 600 million people in 2011, Latin American pharmaceutical sales were at $62.9 billion. LA’s pharmaceutical market represents approximately 25% of global pharmaceutical sales. As a developing market, Latin America is quite complicated and diverse in terms of regulatory, reimbursement, market, demographic, and political characteristics. The harmonization of pharmaceutical regulation has been initiated in conjunction with the creation of regional free trade zones. Five main free trade zones are developing: North American Free Trade Agreement (NAFTA); MERCOSUR; Central America; Andean Area; and The Caribbean Community. Regulatory frameworks overall have improved as a result of free trade and intellectual property agreements. Regulatory enforcement bodies, quality investigators, proactive Good Clinical Practice (GCP) and policy development, have been cited as contributing to Latin America’s explosive growth. Latin American countries are currently moving policies to support productive development and innovation. The local biotechnology industry is developing rapidly.
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拉丁美洲制药概述
拉丁美洲是一个多样化、多肤色和充满活力的地区;在发展中地区拥有最高的预期寿命。在拉丁美洲,持续存在的社会排斥和财富分配以及获得和使用服务方面的不公平现象反映在健康结果中。2011年拉美人口达到6亿,医药销售额为629亿美元。洛杉矶的药品市场约占全球药品销售额的25%。拉丁美洲作为一个发展中市场,在监管、报销、市场、人口和政治等方面都相当复杂和多样化。在建立区域自由贸易区的同时,已经开始协调药品管制。正在发展的五个主要自由贸易区是:北美自由贸易协定;南方共同市场;中美洲;安第斯地区;和加勒比共同体。由于自由贸易和知识产权协议,监管框架总体上得到了改善。监管执法机构、质量调查人员、积极主动的良好临床实践(GCP)和政策制定被认为是促进拉丁美洲爆炸性增长的因素。拉丁美洲国家目前正在制定支持生产性发展和创新的政策。当地生物技术产业发展迅速。
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