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一、前言 世界各发达国家在药品质量监督管理中,对药品生产、供应、使用等过程均建立了严格的监督管理制度和计算机药品质量信息系统。我国“七五”规划中亦明确规定了建立药品监督保证体系的任务,卫生部在《建立国家药品监督保证体系的初步实施方案》中,提出了将现代化科学技术应用于药品监督管理工作的要求。1987年在卫生部的领导下,由卫生部药政局下达了《药品质量监督管理信息系统》(简称《系统》)课题研制任务,并由中国药品生物制品检定所牵头组成了课题研究协作组。经
I. Preface The developed countries in the world have established strict supervision and management systems and computerized drug quality information systems in the process of drug production, supply and use in drug quality supervision and management. In the “Seventh Five-Year Plan” of our country, the task of establishing the drug supervision and assurance system is also clearly defined. In the “Preliminary Implementation Plan of Establishing a National Drug Supervision and Assurance System”, the Ministry of Health has put forward the requirement of applying modern science and technology to drug supervision and administration . Under the leadership of the Ministry of Health in 1987, the Drug Administration of the Ministry of Health issued the task of developing the “Drug Quality Supervision and Management Information System” (referred to as “the system”) subject. The research team led by the China Pharmaceutical and Biological Products Agency led the project. through