Objective: To improve the regulatory system for radiopharmaceuticals, promote the development of the radiopharmaceuticals industry, and meet the needs of clinical medication, by reviewing the current situation and challenges of the development of domestic radiopharmaceuticals. Methods: Using literature research method and combined with work practice, this paper compared the differences in the development of the radiopharmaceutical industry at home and abroad, and analyzed the main problems faced by the domestic radiopharmaceutical industry. Results and Conclusion: Although China’s radiopharmaceutical industry has made significant progress, it still faces many difficulties and challenges, mainly including a large shortage of radiopharmaceutical professionals, a heavy reliance on imports for nuclide supply, a gap between market size and clinical demand, and the need to improve and refine regulatory policies and technical guidance principles.

Objective: To provide references for promoting research and development and improving regulatory measures of radiopharmaceuticals in China by a comprehensive analysis of the global regulatory system for radiopharmaceuticals. Methods: Literature review and comparative analysis were used in this study. By collecting and organizing regulations and guidelines related to radiopharmaceuticals in the United States, European Union, Canada, and China, as well as the structure, functions, and regulatory strategies of their regulatory systems, the characteristics and differences of each country were analyzed. Combining the development trends of the global radiopharmaceutical industry, the new regulatory trends and their potential impacts on the industry were explored. Results and Conclusion: Although there is heterogeneity in the regulation of radiopharmaceuticals, countries are faced with challenges in ensuring the safety, efficacy, and quality control of these drugs. With the rapid advancement of medical technology and the evolving industry demands, there is a pressing need for regulatory frameworks to adopt more flexible and innovative strategies. The global regulatory landscape for radiopharmaceuticals is increasingly focused on expediting the development and approval of innovative drugs, establishing new technological guidelines, simplifying approval processes, and enhancing international coordination and standardization.

Objective: To review and establish the regulatory elements and industry pain points systematically for the whole life cycle management of radiopharmaceuticals in China, to provide the references for the healthy development of radiopharmaceuticals in China. Methods: By literature research method and comparative research method and the industrial practices, the system draft of China’s radiopharmaceutical regulatory elements and industry pain points for the whole life cycle management was basically built up, based on the investigation of domestic and overseas industrial development status, trends and regulatory systems for radiopharmaceuticals. Through the design of a questionnaire survey, the non-probability sampling method was carried out to investigate. At the same time, targeted expert discussions and interviews were carried out to further confirm the completeness and scientificity of the system draft for exploring solution strategies. Results and Conclusion: The established system consists of four levels, namely, six management processes, sixteen first-level regulatory elements, forty-one second-level regulatory elements and fifty-three industry pain points. The results of questionnaire survey and expert discussions and interviews show the completeness and scientificity of the system with the reference value for further suggestions to be proposed.

Objective: To provide a reference for improving the regulatory system of radiopharmaceutical in China. Methods: The particularities, regulatory elements and pain points of all aspects of whole life cycle of radiopharmaceuticals were sorted out,and suggestions were put forward by comparing the domestic and foreign regulatory literatures and combining with comprehensively analysis of expert discussions and interviews as well as questionnaire inquiries. Results and Conclusion: Based on the particularity of radiopharmaceuticals, suggestions were put forward on improving the radiopharmaceutical regulatory system in China, including general suggestions on legal and regulatory frameworks, and the regulatory suggestions at each aspect of the whole life cycle such as research and development, registration, production, circulation, use and environmental impact assessment.

Objective: To study the application and development path of synthetic biology technology in the field of natural product-derived drugs, so as to promote the rational application of synthetic biology technology and the high-quality development of the industry in this field. Methods: Based on the national classification of drug registration management, the relevant laws and regulations were analyzed to study the application of synthetic biology technology to develop the natural product-derived drugs. At the same time, the technical requirements of synthetic biology technology applied to the development of such drugs were studied based on the current drug developing guidelines and specifications. Results and Conclusion: By analyzing the national application path of drug registration classification, it could be concluded that, for the natural product-derived drugs which developed with the synthetic biology technology, there are no stated obstacles in the statutes preventing their registration as traditional Chinese medicine or natural drugs, however, the current technical guidelines are not applicable. If it is a single compound and its structural is identified, it could be registered as the chemical drugs, but the domestic and foreign technical requirements should be considered comprehensively, or some relevant requirements for biological products can be referred to if necessary. Sometimes such drugs may be required to be managed as biological products. The existing regulations and technical requirements for drug research could basically cover the different stages of the development of such drugs, however, there is no clear official guidance on how to reasonably apply them. Further official interpretation is necessary to provide more clear guidance for the industry, so as to promote the rational application of emerging technologies on the basis of ensuring safety and effectiveness, and to promote the high-efficiency and high-quality development of the industry.

Objective: To analyze the current quality status of traditional Chinese medicine (TCM) decoction pieces, with the goal of continuously improving their quality and ensuring public safety and health in medicinal usage, based on national sampling inspection data from 2019 to 2023. Methods: Various research methods including data analysis, case studies, literature reviews, market research, and interviews were employed to analyze the sampling inspection data. Combined with factual survey results and current situation analysis, a comprehensive assessment of the influencing factors and potential risks of TCM decoction piece quality was conducted. Results and Conclusion: Addressing issues such as inadequate quality awareness, complex source control, weak industrial chains, lack of traceability and prevention mechanisms, and limited standards, it is recommended to strengthen quality awareness across the entire industry chain, implement green source quality control, integrate traditional and modern technologies, promote intelligent storage and transportation, improve traceability and evaluation systems, accelerate the transformation of achievements, and enhance supervision.

Objective: To further explore and improve centralized volume-based procurement (hereinafter referred to as “centralized procurement”) rules of the national Chinese patent medicine. Methods: A retrospective analysis was conducted on the documents and implementation of the national centralized procurement of Chinese patent medicines in 2023, summarizing several aspects including the formation of the procurement catalog, the principles of grouping, the determination of qualifying enterprises, the criteria for selecting winning enterprises, and the principles for distributing agreed procurement volumes. Results: The national centralized procurement of Chinese patent medicines established a catalog of 42 drugs across 16 procurement groups. The shortlisted companies are determined based on a comprehensive evaluation of multiple performance indicators, with a focus on reducing costs. The shortlisted companies are divided into large enterprise groups and small enterprise groups, and bid separately for intra product competition. Inter product bidding was set up, bidding for shortlisted products was sorted, and the possibility of enterprise bidding was eliminated. The introduction of a daily cost rule within procurement groups was established to reduce the deviation of selected price. Enterprises offering high-quality products at low prices were given opportunities for revival winning. By rewarding a certain market share, the agreed procurement volumes were allocated to the enterprises with the highest reduction in prices and the lowest daily costs. Conclusion: The new rules for the national centralized procurement of Chinese patent medicines have expanded the scope and optimized the rules, accumulating valuable experience for future enhancements.