我国中药技术标准管理体制的历史与现状--中药技术标准管理体制的战略研究系列(Ⅰ)

为制定我国中药行业的技术标准战略，受国家科技部委托，我们负责中药技术标准管理体制的战略研究部分。中药管理体制在国家制定和实施中药国家技术标准，提高中药产品国际竞争力等方面具有举足轻重的作用。研究分三个部分：1．我国中药技术标准管理体制的历史与现状；2．与中药有关的国际植物药技术标准管理体制研究；3．我国中药技术标准管理体制的问题与对策。研究通过分析我国中药管理的组织机构和所制定的法律法规，研究比较了国际主要国家(地区)与中药相关的植物药管理体制和法律法规状况，提出在制定和实施我国中药国家技术标准时，采取的措施和策略，以及在国际贸易中应设置的相关技术壁垒。本文作为研究的第一部分历史性地回顾了我国中药技术标准的管理体制，从不同层次分析了我国中药技术标准管理的现状，为比较研究提供了基础。

History and Status Quo of Management System in Technological Standards of Chinese Medicines in China-A Series of Strategical Studies on Management System in Technological Standards of Chinese Medicines ( Ⅰ )

In the formulation of the strategy of technological standards in the industry of Chinese medicines in China the authors of this article, entrusted by the Ministry of Science and Technology, are responsible for the strategic study of the management system in the technological standards of Chinese medicines. The management system of Chinese medicines plays a decisive role in the formulation and implementation of the technological standards and the enhancement of international competitiveness of the products of Chinese medicines. Their study includes the following three parts: (1) the history and status quo of the management system in the technological standards of Chinese medicines in China; (2) the study of management system in the technological standards of plant medicines related to Chinese medicines abroad; (3) problems and countermeasures in the management system of the technological standards of Chinese medicines in China. In the study the organization departments for the management of Chinese medicines in the country and the laws and regulations they have made are analyzed, systems and laws and regulations in the management of plant medicines related to Chinese medicines in some major countries ( regions ) of the world are studied and compared, and measures and strategies which should be taken in the formulation and implementation of the technological standards of Chinese medicines in the country and relevant technical barriers which should be set up in the international trade of medicines are put forward. As the first part of the study this article historically reviews the management system of the technological standards of Chinese medicines and analyzes the status quo of the management of the technological standards of Chinese medicines in China at various levels, thus laying a foundation of comparative study in this field.