关键词: font-size:medium, ">药品；抽查检验；对比研究

Abstract: Objective： To contrastively analyze the drug sampling system in China， the European Union， the United States and Japan， and to provide experience and reference for improving the relevant system. Methods： The sampling system of drugs in different countries was summarized and analyzed from the aspects of sampling purpose， main regulations and organizational framework， variety selection， sampling and inspection， announcement and treatment of results. Results & Conclusion： In terms of sampling purposes， countries have similar sampling purposes， including verifying the quality of drugs after marketing. In terms of main laws and regulations and organizational framework， China is more similar to the United States. In both cases， the management department is responsible for the organization work， while the technical department is responsible for the organization and implementation. In the selection of varieties， the United States and the European Union have placed risk assessment in an important position， China has not made full use of this quantitative method to determine sampling varieties. In terms of sampling and testing， compared with the European Union， sampling deviation caused by different climate types is less considered in China′s sampling， and the participation of social institutions in sampling testing is lower than that of the United States. In terms of result announcement and processing， the completeness of data release in China is relatively good， but sampling information from different channels has not been consolidated and unified. The system of drug sampling inspection in China is in the stage of continuous development and improvement， with good performance in organization， implementation and result announcement， etc. However， under the new situation of drug supervision， the relevant experience of foreign countries in variety selection and sampling inspection can still be fully learned. Based on this， the following suggestions were put forward： introducing the risk concept in the selection of drug varieties and constructing the risk assessment model. Taking full account of environmental factors in sampling and actively mobilizing social resources. Strengthen the construction of information platform and enrich the content of drug quality announcements.
  

Key words: font-size:medium, ">Drug；Random inspection；Comparative study