Analysis And Reflection About The Situation Of National Drug Evaluation Sampling And Testing

Drug random sampling and testing is the legal duty given by Drug Administration Law,as well as the important way of supervision and regulation of medicine in China.The drug evaluation random sampling and testing is of important significance to evaluate the overall quality of medicine,help to crack down on producing and selling fake medicines,factors of quality problems of the drugs exist and its influence,then added drug quality management oversight,the whole of the drug quality guidance of national macro control,supervise the drug unit in strict accordance with the standards of drugs production,circulation and use of drugs,to ensure drug quality and stable state in each link,to achieve effective supervision and management of drugs,to provide the basis for improvement of drug quality management,to ensure that the people's drug safety.The basic system and the characteristics of the subject of the first use of literature research on Chinese pharmaceutical listed after the inspection,understand the basic mode of quality supervision and inspection of the foreign drug market,after the listing of foreign drugs on quality supervision and inspection system worthy of our reference;secondly by about 2010-2014 years of national drug evaluation testing data of national drug quality bulletin CFDA released in the transverse and longitudinal comparative analysis of the overall situation of testing for drug evaluation and reflects the problems.Finally,through the research deficiencies of drug evaluation inspection found problems and inspection,to find a solution to the problem,in order to better play to improve the efficiency of drug sampling and testing,provide a reference for drug quality the supervision and management work.This topic is divided into the following five chapters.The first chapter mainly introduces the research background,purpose and significance,research methods and ideas.The second chapter mainly outlines the basic concepts and the necessity of drug quality management,and focuses on the importance of drug sampling and testing,and briefly introduces the system of supervision and inspection after drug listing abroad.The third chapter mainly introduces the course of development of China's drug random inspection system,analysis our country drug random inspection mode,the legal basis of the testing management,testing agencies and testing organization form,with the drug evaluation testing mode,foreign brief post marketing drug supervision and examination test system,and think about foreign drug quality supervision and inspection system of our country the significance.The fourth chapter through the drug quality announcement query the State Food and Drug Administration released during 2010-2014,finishing the main information bulletin released by the statistical analysis of the overall situation of national drug evaluation sampling and testing,found unqualified distribution and main characteristics of medicines.The results showed that: 2010-2014 years of national drug sampling and testing overall quality is maintained at a high level,the testing of qualified rate is 99.34%.but there are many problems such as: substandard drugs in circulation unit a relatively high proportion of traditional Chinese medicine;drug quality should be improved;some enterprises board repeatedly "blacklist".In addition,there are some deficiencies in the work of drug evaluation and inspection,and it needs further improvement.In the fifth chapter Substandard medicines distribution characteristics of.Analysis reasons of the unqualified phenomenon,and the reasons put forward proposals to improve,focus on drug circulation use unit testing,proprietary Chinese medicines quality,tablet dissolution degree are discussed;On the other hand,explore how to further improve the national drug testing mechanism,improve the testing efficiency,strengthen the testing information and staff construction,in order to improve the efficiency of supervision,to ensure the effectiveness of the drug safety for the people.