进口(含港、澳、台)化学药品临床试验批准.x.review要点.docxVIP

进口（含港、澳、台）化学药品临床试验批准 Approval for clinical trials of imported (incl. from Hong Kong, Macao and Taiwan) chemicals 2012年11月05日 发布 一、项目名称：进口药品注册 I. Project name: Imported Drug Registration 二、许可内容：进口（含港、澳、台）化学药品临床试验批准，其分类按《药品注册管理办法》附件二注册分类，即： II. Content of licensing: Approval for clinical trials of imported (including Hong Kong, Macao and Taiwan) chemicals, which are classified in accordance with Annex II of the “Provisions for Drug Registration”, namely: 注册分类1、未在国内外上市销售的药品。 Registration Category 1, drugs not marketed at home and abroad. 注册分类3、已在国外上市销售但尚未在国内上市销售的药品。 Registration Category 3, drug