业务
获得药品
质量(理念)
投资(军事)
市场准入
监管机构
工作(物理)
任务(项目管理)
过程(计算)
发展中国家
营销
经济增长
政治学
公共行政
经济
管理
地理
计算机科学
工程类
法学
机械工程
哲学
考古
认识论
政治
农业
操作系统
作者
Nandini Pasam,Raju Kamaraj
出处
期刊:Journal of medical pharmaceutical and allied sciences
[Society of Pharmaceutical Tecnocrats]
日期:2022-01-30
卷期号:11 (1): 4332-4339
标识
DOI:10.55522/jmpas.v11i1.2158
摘要
Registration of medicinal products is a challenging task in various countries as the regulatory requirements differ from country to country around the world. Like in regulated countries medicinal products regulation is a difficult piece of work in Semi-regulated countries as they are not coordinated. Being the sixth most populous country, Brazil gives a great opportunity for the bio/pharmaceutical market. Superior health maintenance, high quality, and modern medicines are being demanded by Brazilians which gives a huge opportunity for overseas investment. Medicinal products registration is a lengthy process in Brazil. Obtaining access to the marketing of drugs and biologics from the Brazilian Regulatory Authority is not an easy business for bio/pharmaceutical companies. One of the most difficult tasks facing regulatory agencies is ensuring that medications are manufactured in accordance with the country's regulatory requirements. This Review article's primary objective is to explain how pharmaceuticals and biologics are regulated and registered in Brazil. Keywords: Brazil, ANVISA, Drugs, Biologics, Regulation.
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