Objective To provide a theoretical basis for the adjustment of the registration classification of China’s biological products, and to establish a continuously improved registration classification system. Methods Based on literature research, the specific classification methods, classification principles and considerations of biological registration in China, the United States and the European Union were studied to form a complete comparative analysis. Results and Conclusion It is recommended that the division between therapeutic and preventive use should beremoved from the registration classification of biologics. The therapeutic, preventive and diagnostic use of the product should be limited as part of the product specification, and the registration should be classified according to the development of biotechnology, innovation, modification and bio-similar drugs. In addition, the supervision of registration of advanced therapeutic products should be different from that of traditional biologics.

Objective To study the inheritance and innovation of traditional Chinese medicine, and to offer an insight for the public. Methods Literature review, data retrieval and systematic analysis were used to elaborate and summarize the influence of changes in related classification and policy reform of traditional Chinese medicine (TCM) registration on its inheritance and innovation. The study was carried out in the context of the TCM registration related classification and policy reform and evolution on TCM inheritance and innovation. Results and Conclusion TCM registration plays an important role in the inheritance and innovation of TCM, which greatly influences on its inheritance and innovation. The reform of new registration classification respects the law of TCM research and development, reflecting the establishment of the review and approval system in line with the characteristics of TCM inheritance, which promotes the research and development of new drugs. The establishment of the review and approval system also accelerates the marketing transformation of new traditional Chinese medicine. TCM innovation should attach importance to clinical value orientation and improve the scientific connotation of TCM. Meanwhile, the advantage of China’s accession to ICH, PIC/S and other international drug certification organizations should be taken to speed up the construction of international mutual recognition of TCM standardization system, which can provide a broader path for the inheritance and innovation of TCM in the new era.

Objective To analyze the problems of China’s pharmacovigilance legislation, and to provide some suggestions for improving it. Methods Relevant literature at home and abroad were studied to compare the laws and regulations of the United States, the European Union, Japan and China. Then, the problems of China’s pharmacovigilance legislation were analyzed. Results and Conclusion The Chinese pharmacovigilance legislation has such problems as nontransparent formulation process, poor dynamic adaptability, insufficient use of the attention mechanism, fragmentation of laws and regulations, and poor connection of laws and regulations, which should be optimized. It is recommended to carry out theoretical and methodological research on pharmacovigilance legislation to provide practical guidance for optimizing pharmacovigilance legislation with Chinese characteristics.

Objective To discuss the flexible supervision and communication mode in the post-approval change (PAC) of drugs, to explore how to ensure the quality and availability of drugs during the changes, and to provide some suggestions and reference for promoting the timely marketing of drugs. Methods Based on the comparability protocol guidelines issued by the US FDA in October 2022, the regulatory status quo of PAC between China and the US was compared to explore the feasibility of implementing comparability protocols in China. Results and Conclusion According to the specific situation of post-approval of drug change supervision, some suggestions were put forward to optimize the PAC management procedure, such as establishing the communication pathways between holders and health authorities, publishing relevant guidance and strengthening training, so as to provide reference for the implementation of comparability protocols in China.

Objective To analyze the current research status and development trend of active surveillance of drug safety in China, and to provide reference and suggestions for future research. Methods Using bibliometric methods and with the help of the CiteSpace 6.1.R6, the literature on active surveillance of drug safety in CNKI from 2010 to 2022 was visualized and analyzed in terms of authors, institutions and keywords. Results and Conclusion The research on active surveillance of drug safety in China started late and is in a stable development period. Some Chinese scholars have done more work on active surveillance of drug safety. Additionally, a number of institutions have published some articles and surveillance objects, surveillance methods, and surveillance results are the main research content. However, the cross-institutional cooperation is not close. The traditional Chinese medicine injection, centralized surveillance, and automatic surveillance are the hot spots of research. It is the latest research frontier to use the Chinese hospital pharmacovigilance system to actively monitor drug safety. At present, the research related to active surveillance of drug safety in China is still in the early stage, and more in-depth research is needed to follow up.

Objective To explore the risk management of the changes of sponsors and/or production sites during drug clinical trials based on the theories of quality management, risk management, and change management. Methods The method of failure modes and effect analysis (FMEA) was used to identify risks through literature research, expert consultation, comparative research, and comprehensive analysis. Besides, risk priority number (RPN) was used to evaluate the risks. Results and Conclusion A FMEA of the changes of sponsors and/or production sites in clinical trials was constructed and RPN values of every failure mode and causes were obtained. Based on the RPN values, the core risk control points for different combination modes of sponsors and/or production sites after their changes were identified. It is recommended that China should strengthen the construction of the sponsor responsibility system. In addition, the changes of sponsors and/or production sites during the clinical trial period should be allowed in an orderly manner under the premise of ensuring the quality of clinical trials and subject protection.

Objective To study the cases of public-private partnerships (PPPs) commonly used in Europe Union and the United States to solve common challenges such as the decline in drug R&D efficiency, and to provide reference for developing countries to deal with these challenges in drug R&D. Methods Multiple case study method was used to make a comparative analysis of three PPP models in European Union and the United States. Results and Conclusion Third-party conveners, project-based cooperation models, and PPP funding mechanisms were key elements of PPP models in European and the United States. The developing countries should establish new PPP mechanisms to solve common challenges in drug R&D in their countries based on national conditions and key elements of PPP models.

Objective To explore the impact of mergers and acquisitions (M&A) on the innovation performance of the companies from both a patent perspective and a financial perspective by taking the case of M&A Company J as an example. Methods The literature research method, patent data analysis method, and financial data analysis method were used. Results and Conclusion The M&A has a positive impact on the innovation performance of Company J, and the results from the patent perspective and the financial perspective are consistent. The literature research method, patent data analysis method, and financial data analysis method were used. The M&A has a positive impact on the innovation performance of Company J, and the results from the patent perspective and the financial perspective are consistent.

Objective To study the causal relationship between R&D investment and enterprise performance of domestic pharmaceutical enterprises. Methods Panel data model was adopted for empirical analysis. Results and Conclusion Increasing the R&D investment intensity of pharmaceutical enterprises in the Yangtze River Delta and Zhejiang by 1% will increase their profit margins by 0.79% and 0.46%. On the contrary, if the profit margin increases by 1%, the R&D investment intensity will increase by 0.25% and 0.19%. If the profit margin of pharmaceutical enterprises in Beijing, Tianjin, Hebei, Chengdu, Chongqing and other regions increases by 1%, the R&D investment intensity will increase by 0.14%, 0.07% and 0.1%, respectively, which are lower than those in the Yangtze River Delta and Zhejiang. The relationship between R&D investment and enterprise performance of pharmaceutical enterprises in the Yangtze River Delta and Zhejiang Province is Granger causality, showing a two-way positive effect. Profits and R&D investment of pharmaceutical enterprises in Beijing, Tianjin, Hebei, Chengdu, Chongqing and other regions are also Granger causality. But in the Pearl River Delta, profits and R&D investment have not passed the stability test, it is impossible to determine the causality between them.

Objective To evaluate the cost-effectiveness of gadopentetate dimeglumine (Gd-DTPA) and gadobenate dimeglumine (Gd-BOPTA) magnetic resonance imaging (MRI) contrast agents for the early diagnosis of hepatocellular carcinoma (HCC) from the perspective of China’s healthcare system. Methods A decision tree + partitioned survival model was constructed for early diagnosis of HCC based on literature data. Taking quality-adjusted life year (QALY) as the main health outcome measure for incremental cost-effectiveness ratio (ICER) analysis, the sensitivity analysis by Monte Carlo simulation was constructed to generate corresponding tornado diagram, incremental cost-effectiveness scatter plot, and cost-effectiveness acceptability curve. Results and Conclusion The basic analysis results showed that the ICER value of Gd-BOPTA diagnostic scheme compared with Gd-DTPA diagnostic scheme was 17 302.46 yuan/QALY, which is less than 1 times of China’s gross domestic product (GDP) per capita. The sensitivity analysis results showed that the cost of delayed treatment and timely treatment had a significant impact on the results. When the willingness to pay (WTP) was 1 time of GDP per capita, the probability of cost-effectiveness advantage of Gd-BOPTA diagnostic scheme was 65.30%. When the WTP value is set at 1 times of GDP per capita, Gd-BOPTA MRI has cost-effectiveness advantages for the early diagnosis of HCC.