Leaflet Normative Research

According to the" Drug Administration Law" provisions, drugs must be accompanied by instructions. In order to standardize the management of the drugs manual and labels, in March15,2006the State Food and Drug Administration announced the" provisions on the administration of the drugs manual and labels"(Bureau No.24), requirement our country listed drugs manual and labels should be consistent with the Bureau order No.24. However, there exist a lot of problems of manual of medicines and chemical reagents, the resulting warning defects has been more and more valued by the drugs production enterprise. From carbamazepine case, Wenjiang Fuling pill case also showed the drug specifications in tort liability also has a lot of controversy. In view of this, this paper attempts to regulate aspects of drug instructions.In this paper, except the introduction and conclusion, is divided into four chapters, the main contents are as follows:The first chapter review and statistics with the drug instructions related to the current laws and regulations, introduced our country now drugs manual management mode. To the existing laws and regulations as the basis for drug instructions, clear management status.The second chapter focuses on the analysis of351drug instructions, statistics and analysis of these medicines in specific existing what problem, access to relevant information and do finishing, that the three kinds of problems:a general class of error analysis, the fundamental class of error analysis, serious error analysis. And for each of the relevant laws and regulations and understanding.The third chapter analysis of related problems of drug instructions from administrative angle and defect analysis of manual of medicines and chemical reagents, for the presence of drug instructions should be open but now most did not publicly," Pharmacopoeia" and other related standards non-standard problem such as well as drug specifications fully is limited, the drug instruction can understand a certain standard. To express. Combination drug characteristics, in-depth analysis and understanding.The fourth chapter proposed drug specifications developed and perfect, present drug instructions should be clear of manual of medicines and chemical reagents specific population, drug production enterprises should be strictly treated as well as for drug standard revision.