美国药品监管的主管机构美国食品与药品管理局(FDA)在保证药品、医疗器械等产品质量、安全方面积累了丰富的管理经验,享有杰出的国际声誉,是当今世界公认的药品政府监督管理权威。本文将侧重于对属于产品市场准入监管范畴的新药审批制度的论述。 The U.S. Food and Drug Administration (FDA) has accumulated rich management experience in ensuring the quality and safety of pharmaceuticals, medical devices and other products and enjoys an outstanding international reputation. It is recognized as the authority of drug administration in the world today . This article will focus on the discussion of new drug approval systems that fall under the regulatory scope of product market access.