中国药品监管工作介绍 Drug Supervision and Administration in China 方来英 Fang Laiying June 16, 2015
Drug Supervision and Administration in China 1. 药品监管的机构 1.Drug supervision and administration authority 2. 药品监管的法律 2. Laws and regulations for drug supervision and administration 3. 药品销售的渠道 3.Market channels for drug
1. 药品监管的机构 Drug supervision and administration authority 中国设有国家食品药品监督管理总局, 属于国务院直接管理的正部级机构 China Food and Drug Administration, a ministerial department directly supervised by the State Council, was established for drug supervision and administration. Present Past 2013 年国务院机构改革 Restructuring of the State Council in 2013
1. 药品监管的机构 Drug supervision and administration authority Ø 国家食品药品监督管理总局在药品监督方面主要职责 ØMain responsibilities for China Food and Drug Administration in drug supervision: - ThemeGallery is a Design Digital Content & Contents mall developed by Guild Design Inc. - ThemeGallery is a Design Digital Content & Contents mall developed by Guild Design Inc. - ThemeGallery is a Design Digital Content & Contents mall developed by Guild Design Inc.
1. 药品监管的机构 Drug supervision and administration authority
1. 药品监管的机构 Drug supervision and administration authority - ThemeGallery is a Design Digital Content & Contents mall developed by Guild Design Inc. - ThemeGallery is a Design Digital Content & Contents mall developed by Guild Design Inc. 省市自治区及以下的药品监督部门主要负责机构设立的批准和生产经营活动的合法合规 Drug supervision and administration authorities at provincial, municipal and autonomous region level or below are mainly responsible for approving the establishment of institutions and supervising legal compliance of production and operation.
2. 药品监管的法律 Laws and regulations for drug supervision and administration 法律 Law 一部药品监督管理的专业法规, 即 中华人民共和国药品管理法 The Drug Administration Law of the People s Republic of China, a law dedicated to drug supervision and administration 行政法规 Administrative Regulation 国务院颁布有行政法规 中华人民共和国药品管理法实施条例 The State Council promulgated Regulations for Implementation of Drug Administration Law of the People s Republic of China 部门规章 Departmental Rules 按照法律的授权, 国家食品药品监督管理总局以局长令的形式发布了若干行政规章 In accordance with statutory authority, China Food and Drug Administration has also issued several administrative rules by way of Ministerial Order
2. 药品监管的法律 Laws and regulations for drug supervision and administration 按照这些法律的规定, 在中国境内, 药品必须经过国家批准才能够生产 交易 使用 对于从事药品生产和商业活动的单位, 必须经过许可批准 任何药品的人体临床试验也必须经过批准方能够在指定的机构进行 According to these laws and regulations, drug can only be manufactured, traded, and used with state approval. Entities must obtain license and approval before they engage in the production of drug and relevant commercial activities. Clinical trails of any drug on human can only be conducted in designated organizations upon approval. 市场准入 Market Access The market accessof drug requires documents such as the production license issued by China Food and Drug Ad ministration, usually including New Drug Certificate, Production Approval Number, etc.. 生产经营 Production and commercial activities Organizations and business entities shall only produce drug and conduct relevant commerical activitieswith the approval documents issued by China Food and Drug Administration and its authorized departments. Production and commerical activites must conform to technical standards such as GMP/GSP.
3. 药品销售的渠道 Market channels for drug 零售终端 Terminal of retail 医疗机构 Medical institutions 中国药品市场的终端主要是医疗机构, 由于医疗保险的限制, 医疗机构要占到药品零售额的 70% 左右 药品的零售终端虽然数量众多, 但是规模较小, 销售量不多 Medical institutions are the major terminals in China s drug market. Due to restraints of medical insurance, medical institutions account for about 70% of the retail sales of drug. Though there are many terminals of retail for drug, they are small both in terms of scale and sales volume.