ABSTRACT
OBJECTIVE:To establish an effective technical system to achieve the informatization management in drug produc-tion process,and provide reference for the drug informatization management during production process in China. METHODS:Through analyzing the common problems existing in informatization management in drug production process,above problems were solved by interactive integration marketing system(IIMS)based on mobile internet. Informatization supervision was conducted for the production progress of a batch of drugs in a pharmaceutical production enterprise,and feasibility of the technical system was in-vestigated. RESULTS:There were problems commonly existed in the production process,such as supervision and data collection out of touch,no advanced means,delayed and closed informatization transmission,high cost of informatization collection,hard to develop,etc. IIMS consisted of transit label,informatization collection terminal and monitoring management platform had achieved batch production records paperless data interaction and solved informatization interaction and supervision issues in process of drug quality. In the actual study,IIMS totally supervised 15 links from raw materials purchasing to finished products,and all data were successfully collected. IIMS achieved the real-time remote control of data to make the government easy to regulate,without chang-ing the operational processes,and did not cause economic burden to the enterprises. CONCLUSIONS:The technical system is suit-able for the informatization management in drug production process in pharmaceutical production enterprise,and it can be extended to the scientific research institutes and drug supervision departments in the further.
ABSTRACT
OBJECTIVE:To provide reference for strengthening drug regulation in drug administration department. METH-ODS:Drug regulatory statistical yearbooks during 2011-2015 were collected. Literature analysis,content analysis,comparative analysis and secondary analysis were conducted to analyze and explore the drug production license,business license,advertising ap-proval,protection of TCM varieties,drug complaints,investigation and punishment of drug cases,etc. in statistical yearbook. RE-SULTS & CONCLUSIONS:The number of drug manufacturers and operating enterprises had been increasing year by year,while the retail chain stores in certified enterprises showed tendency to go beyond the single retail pharmacy. Compared with the down-ward trend of number of approved drug advertisements,the number of protected varieties of TCM decreased more obviously. The increase in number of drug complaints did not cause the number of investigated and punished drug cases at the same time,which showed a downward trend. It is suggested to further improve the quality and efficiency of drug regulatory work in China by strict drug production license approval,reforming drug advertising regulation and TCM varieties protection system,intensifying efforts to investigate and punish drug complaints and cases,and playing the supervision of public opinion role of the media and the masses.