全球主要药事执法机构比较.pptVIP

EMEA的委员会 人用药品委员会（Committee for Medicinal Products for Human Use ，CHMP） 兽药委员会（Committee for Medicinal Products for Veterinary Use， CVMP） 罕见病药委员会（Committee on Orphan Medicinal Products ，COMP） 草药委员会（Committee on Herbal Medicinal Products ，HMPC） 七、药事执法机构比较的启示 执法机构的管制产品 执法机构的权限 与卫生行政部门的关系 监督管理体制（垂直与相对垂直） 同消费者之间的关系 平衡消费者和制药工业界的关系 有充足的资金保障 机构队伍的多学科、素质的提高 重视宣传 善于抓住机遇，促进监督 * The Food and Drug Administration is one of the nations oldest and most respected consumer protection agencies. This presentation will tell you about FDAs responsibilities, the tools we use to fulfill those responsibilities, and our priorities for improving the way we serve the public. Stated most simply, FDAs mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use * Our purpose today is to put a human face on the Food and Drug Administration. First, here are a few examples of our accomplishments and how they may have affected you and your family * FDA has streamlined its review process in recent years to help speed important new medical treatments to patients. For example, the average review time for an innovative new drug is now only 6 months, and some have been approved even faster. Products receiving accelerated reviews include new treatments for breast cancer; a rapid, reliable diagnostic test for pneumonia; and devices to improve the monitoring and treatment of diabetes * The last several years have seen an increase in the number and severity of food-borne illnesses around the country. FDA has launched a major initiative to prevent the spread of these food-related infections. The initiative promotes safer food-handling practices by producers and consumers, and more effective detection, tracking and prevention of food-borne illness * A similar initiative aims at improving the safety practices in the blood banking and plasma industries. FDA works to contin