ABSTRACT
OBJECTIVE：To provide ideas for the development of electronic prescription （e-prescription）service mode under the background of “Internet+”. METHODS ：Retrieving official websites and related online resources of the national and provincial governments，health committees ，medical products administration ，and medical security bureaus （up to Jun. 2020），relevant policies，supporting documents and implementation status of e-prescription service mode were sorted out and analyzed ，and the suggestions were put forward. RESULTS ：Current e-prescription service modes included four modes ，such as pharmaceutical retail enterprise e-prescription service mode ，medical institution e-prescription information sharing service mode ，internet hospital e-prescription service mode ，and medical e-commerce e-prescription service mode. The pilot of e-prescription service mode of drug retail enterprises covered the widest range of provinces and cities ，but the participation of health departments and medical institutions was insufficient ，and the pattern of comprehensive power had not been formed. The medical institutions e-prescription information sharing service mode was mainly composed of three typical examples ，namely“Wuzhou mode ”，“Fuzhou mode ”and “Gansu mode ”. However ，it had not been unified in terms of technical standards ，access conditions ，exit mechanism and execution process，etc. At present ，this model was still in a small scope of exploration and pilot stage. The internet hospital e-prescription service mode was limited by the popularization of internet hospital medical insurance payment and the improvement of corresponding rules and regulations ，which was still at the stage of cautious pilot exploration. Medical e-commerce e-prescription service model was limited by the types of drugs within the legal service scope. Meanwhile ，the industry standards and regulations of e-prescription service were in the absence at present. CONCLUSIONS ：As an innovative service mode ，the e-prescription service mode meets the real needs of the pharmaceutical retail industries ，medical institutions and patients. Each pilot mode conforms to the development trend of “Internet+”and shows a strong development momentum ，but overall it is still in the early stage of active exploration. It is urgent to further explore and research around the leading departments ，stakeholders and prescription transfer procedures.
ABSTRACT
OBJECTIVE：To provide reference for optimizing resource allocation and precise investment of China ’s pharma- ceutical industry. METHODS ：The number of invention patent applications in China ’s pharmaceutical industry was searched from China Intellectual Property Netwerk ，and the status quo and structure of patent applications in China ’s pharmaceutical industry were analyzed. SPSS 23.0 software was used to analyze the input-output correlation of the number of invention patent applications with R&D investment and main business income of pharmaceutical enterprises in China. RESULTS ：The number of invention patent applications in China ’s pharmaceutical industry increased year by year. From 2000 to 2015，225 861 invention patents had been applied by domestic applicants and 43 149 invention patents had been applied by foreign applicants in China ；only 49.94％ domestic applicants applied for professional invention ，while 96.79％ of foreign applicants applied for professional invention. There was a positive correlation between the R&D expenditure of pharmaceutical enterprises and the number of invention patent applications，which indicated that the R&D investment of pharmaceutical industry in China was beneficial to the invention patent applications. The number of invention patent applications of pharmaceutical enterprises was also positively correlated with the main business income ，indicating that the increase of invention patent applications of pharmaceutical enterprises also effectively expanded the economic scale of pharmaceutical industry. CONCLUSIONS ：Compared with foreign countries ，the structure of patent applicants in domestic pharmaceutical industry needs to be adjusted urgently. Pharmaceutical enterprises have not yet become the main applicants. The continuous R&D investment of pharmaceutical enterprises effectively promotes the application of invention patent，expanded the economic scale of the pharmaceutical industry.
ABSTRACT
OBJECTIVE：To pro vide suggestions for imp roving the quality of ethical review of drug clinical trials in China and protecting the rights and interests of subjects. METHODS ：Guided by risk management theory ，the literature research method ， expert opinion method and analytic hierarchy process method were used to sort out the ethical review process of drug clinical trials ， extract and determine the risk factors that affect the quality of ethical review ，and determine the weight of each risk factor. Suggestions were put forward improving the ethical review of drug clinical trials in China. RESULTS & CONCLUSIONS ： Established ethical review risk index system of drug clinical trials included 31 influential factors of 5 aspects；the order of importance（weights）of 5 aspects affecting the quality of ethical review of drug clinical trials was as follows ：the construction of the medical ethics committee （0.263 5），the management of review meetings （0.251 4），follow-up review （0.194 5），the acceptance and processing of review applications （0.189 2），and the management of documents and files （0.101 4）. The influential factors with high weight included “withdrawal of people with conflict of interest in the discussion and voting process （0.078 7）” “timely review or conference discussion of scheme modification ，informed consent modification ，serious adverse events ，etc. （0.070 5）”“clarification and external exhibition of the work process and time of ethical review （0.059 8）”“unified and standardized review standards and approval standards （0.052 1）”，etc. The quality of ethical review can be improved by avoiding people with conflict of interest in the discussion and voting process ，timely reviewing or holding ethics meetings on scheme modification ， informed consent modification ，serious adverse events ，etc.，clarifying the working process and time of ethical review ，and establishing unified and standardized review standards and approval standards.
ABSTRACT
In this review, we provide a comprehensive overview on the registration of proprietary Chinese medicines (PCMs) in China over the past century by examining published literature and historical data. We will examine this evolving administrative practice for PCMs registration in China, which is divided to the following five stages: (1) initial measures (1915-1948); (2) early development (1949-1965); (3) provincial approval and trial implementation of the "approval number" system (1966-1984); (4) legislation and cleanup (1985-1999); and (5) centralized national approval (2000 until now), offering a panoramic view on the characteristics of PCMs registration management in China.