Chinese patent medicine is one of important parts in Chinese drug market. It is imperative for new drug development and drug policy-making to establish a drug value assessment framework of Chinese patent medicine embodying the characteristics of traditional Chinese medicine. In this study, PubMed, CNKI and other domestic and foreign literature databases as well as the major international government and academic websites were searched to collect literature, policies, standards, guidelines and expert opinions related to drug value assessment at home and abroad. The methods of literature analysis, content analysis and expert consultation were comprehensively adopted to interpret, compare and analyze the relevant laws and regulations. We obtained the core elements and index system of drug value assessment in the world. According to the characteristics of Chinese medicine and the extensive expert consensus, a set of value assessment framework of Chinese patent medicine covering the whole life cycle from the establishment of the R&D project, pre-clinical application, new drug certificate application and post-marketing use is established, providing strong support for the research and development of new Chinese medicine, post marketing re-evaluation, establishment of clinical medication guidelines, drugs pricing, medical insurance compensation and medication choice of patients.

Results from large-sample double-blind randomized controlled trial (RCT) have always represented the highest level of evidence-based medicine clinical evidence, but it cannot solve all the clinical research problems, thus real-world evidence (RWE) based on the perspective of real-world research (RWS) has developed rapidly. This paper aims to provide reference for the further application and development of RWE by comparing the differences between RWE and randomized controlled trial evidence in data source, internal and external effectiveness, evidence level, application scope, experiment design, implementation elements and implementation cost.

This paper is expected to provide reference for China to establish appropriate standards to evaluate the adaptability of real-world data, and facilitate the establishment of related systems for medical device approval and supervision. Finding appraised standard to evaluate the suitability of real-world data by analyzing the series of factors in the “Use of Real-world Evidence to Support Regulatory Decision-Making for Medical Devices”, in order to turn real-world data (RWD) into a truly practical real-word evidence (RWE). The adaptability assessment of China's RWD can be carried out from 2 aspects such as relevance and reliability. In the aspect of RWD relevance assessment, evaluation criteria can be designed from 5 aspects: data source and selection, data validity, regulatory requirements, ethical issues as well as operability. In the aspect of real world data reliability assessment, evaluation criteria can be designed from 3 aspects: management process standardization, data standardization and quality control.

This article aims to provide reference for China to use real-world evidence (RWE) in drug approval and regulatory decision-making system. The main content of “Real-World Evidence Program” issued by US FDA was summarized by literature research method, and the construction of related systems in China were analyzed. To promote the application of real-world research for drug regulatory decisions, China should publish guidelines related to real-world research, promote the construction of data standards and shared database, extensively introduce the demonstration projects as well as strengthen the guidance for real-world research of enterprises. And at the same time, the relationship between stakeholders should be paid attention to deal with.

At different stages after establishment of the new China, with the constant change of narcotic drugs and psychotropic substance types, as well as drug abuse situation in domestic and overseas, the policy and system of the narcotic drugs and psychotropic substances in China constantly adapt to the complex situation under the inheritance and adjustment, and followed up to adjust the catalogues of narcotic drugs and psychotropic substances, as far as possible to adapt to the requirement and the situation of the drug regulation and anti-drug struggle. Based on a series of laws and other normative documents successively issued by Chinese government about the narcotic drugs and psychotropic substances, according to the major changes of the catalogues or the listed control system of the narcotic drugs and psychotropic substances, the catalogue changing process (1949—2019) of the narcotic drugs and psychotropic substances in China can be divided into five periods, and then this paper systematically analyzes the main contents, characteristics, causes, significance of the catalogue changes of narcotic drugs and psychotropic substances. This paper also provides a retrospective research in response to the current increasingly complex control problem of the narcotic drugs and psychotropic substances, in order to improve the listing management system.

The aim of bio-distribution study is to investigate the performance of medicine reaching the target organs after it was administrated to the human body, as well as its metabolism and clearance process with the time extending. Bio-distribution is a particular and feature research area specific for gene therapy medicines. It could lead severe hazards when human body exposing exogenous gene segments, thus it's necessary to adopt appropriate methods to monitor the state of gene segments of medicines inside the human body to predict potential safety risks. Currently, many regulatory authorities request to carry out bio-distribution research in preclinical study and provide relevant data and information before application in clinical trials. This article mainly generalizes the testing items, types and features of samples, analytical methods and detective strategy of bio-distribution study to provide the industry and regulatory agency with detailed and practical guidance for these kinds of researches and consequently prompt the regulation science in China in the field of preclinical evaluation and assessment.

Minodronic acid is a third-generation nitrogen-containing heterocyclic bisphosphonate drug mainly used for the treatment of osteoporosis and hypercalcemia caused by osteoporosis and malignant tumors. Through summary of the existing literature, it was found that the research on the synthesis of minodronic acid is mainly concentrated on the synthesis of the key intermediate 2-(imidazo[1,2-a]pyridin-3-yl) acetic acid, and the preparation of this intermediate is mainly based on the fact that the 3-position of the imidazo[1,2-a]pyridine's structure contains a substituent group which is susceptible to functional group conversion. The synthesis technology of minodronic acid by phosphorylation of this intermediate is relatively simple. The synthesis strategy of the key intermediate 2-(imidazo[1,2-a]pyridin-3-yl) acetic acid is reviewed in this article.