Objective: To compare the regulatory policies of various provinces on the storage and transportation of drug third-party logistics, and to put forward feasible suggestions for strengthening the supervision of drug third-party logistics. Methods: By searching the websites of the National Medical Products Administration and provincial medical products administration, the regulatory policies on drug third-party logistics storage and transportation were obtained, the policies of diff erent provinces and the relevant provisions of the Good Supply Practic were compared and analyzed, and suggestions were put forward. Results: Through comparison, it was found that the policies of various provinces on storage and transportation mainly focused on the storage area, storage facilities and equipment, cold storage quantity and volume requirements, cold storage power supply guarantee, temperature and humidity monitoring system, storage management system, vehicle quantity and vehicle equipment, transportation vehicle management, special drug transportation, transportation management system and other aspects. However, there were some diff erences in the specifi c regulations of diff erent provinces. Moreover, the policy documents of most provinces still had problems: storage management policies were not unifi ed, storage areas were not clearly divided, storage facilities and equipment provisions were not specific, transport-related policies were not comprehensive, and provisions were not made to ensure the normal temperature environment during the transportation of normal temperature drugs. Conclusion: Drug regulatory authorities should strengthen the scientifi c supervision of drug third-party logistics, and establish a unifi ed third-party logistics management system. Drug third-party logistics enterprises should strengthen the construction of infrastructure and equipment, and strive to improve their own storage and transportation level. All relevant parties should make joint eff orts to promote the healthy and orderly development of the pharmaceutical third-party logistics industry.

Objective: To review and summarize the development and regulatory inspection documents ofimmune cell therapy products, and provide reference for the production and supervision of such products.Methods: The production characteristics of immune cell therapy products were organized and analyzed, andregulatory guidelines and reference documents in China were introduced, some key points that need to be takeninto account by on-site inspections for this type of products were also summarized. Results and Conclusion:Compared with traditional drugs, cells as drug have multiple unique characteristics. Therefore, there are challengesin production management, quality control, and systemic contamination risks caused by diff erent products to beproduced on the same line. This article proposes suggestions for on-site inspection and risk assessment of immunecell therapy products from the perspective of provincial regulatory authorities, combined with the productionprocess of immune cell therapy products. We hope to further improve the post-marketing supervision system ofimmune cell therapy products.

Objective: To put forward reasonable suggestions for further improving the review and filing ofdrug instructions. Methods: From the perspective of confirming the inspection standards by institute for drugcontrol, the problems encountered by institute for drug control in determining the implementation standardsaccording to the drug instructions were analyzed, combined with personal work experience and thinking. Results:The [executive standards] item specifi ed in some drug instructions lacked the indicative documents for standardrevision, was not revised in time, and had non-standard writing. Conclusion: It is suggested that enterprisesshould update the drug instructions timely and accurately, and the drug supervision department should strengthenthe dynamic management of the drug instructions in the daily supervision work.

Objective: To propose several suggestions for improving China's pharmaceutical excipient management system by comparing the core elements of China's pharmaceutical excipient joint review and the Drug Master File system in the United States. Methods: A comparative study was made on the six core elements of China's pharmaceutical excipient joint review system and the US DMF registration, including registration scope, registration subject, registration data requirements, integrity review, joint review, and change management. Results and Conclusion: The core elements of China's pharmaceutical excipient joint review system were basically consistent with the US DMF registration system. However, it is not diffi cult to fi nd that there is room for further improvement in the management of pharmaceutical excipient in China at some conceptual and practical levels, including the risk-based management concept that needs to be further implemented, the signifi cance of registration status needs to be further clarified, and the change management of excipients that can be further optimized.

Objective: To help relevant personnel to further understand the new specifi c requirements of WorldHealth Organization (WHO) on National Regulatory Authorities (NRA) assessment, and further promote themanagement level of medical product inspection and testing and vaccine batch issuance by introducing anddeeply studing on the Global Benchmarking Tool (GBT) and benchmarking process used by the WHO forNRA evaluation. Methods: The article introduced the GBT framework, analyzed and summarized the ninemajor sections of GBT, and studied the process and application progress of WHO's adoption of GBT for NRAassessment, and its enlightenment to China. Results and Conclusion: The GBT tool set a series of indicatorsand 268 sub-indicators to evaluate the nine functional sections of the national regulatory system, and introducedthe concept of 4-level maturity level (ML); the formal benchmarking process included fi ve steps: submitting aletter of intent, assessing the letter of intent, reaching an agreement on the scope and roadmap of the assessment,conducting a formal assessment, announcing a decision, and listing; as of October 2022, the WHO has announcedthat a total of 12 countries have passed the NRA assessment based on GBT. The NRA assessment of vaccines inour country has reached the ML3 level, but it still needs further improvement and continuous eff orts to reach theML4 level.

Objective: Chinese herbal medicine (called "Crude Medicine" in Japan) belongs to traditionalChinese medicine drugs and is also the raw material of traditional Chinese medicine preparations. Due tonatural attributes, whether the source is a genuine producing area or not is directly related to and aff ects thequality of its own and subsequent preparations. Neighboring Japan has made practice in various directions fromChina on how to establish the fi rst barrier of quality assurance through laws and regulations. To improve thequality of Chinese medicinal materials and subsequent preparations by actively referring to the relevant practiceof Japan. Methods: Through the analysis of the current laws and regulations and implementation measureson the administration of pharmaceutical aff airs in the genuine producing areas of Chinese herbal medicine inChina and Japan, the similarities and differences of their legislative purposes and implementation methodswere compared. Results: The article summarized the essential characteristics and actual effects of the lawsand regulations management of the two countries on the genuine producing areas of Chinese herbal medicine.Conclusion: It provides theoretical basis for reference standard for the further improvement of the pharmaceuticaladministration laws and regulations and the implementation measures in the genuine producing areas of Chineseherbal medicine.

Objective: To promote the coding management of drug production sites in China, promote the digital management of the entire lifecycle of drugs, and improve the level of intelligent drug supervision. Methods: The necessity and feasibility of the coding management of the drug production sites in China were analyzed, through literature review, expert consultation, and survey research, based on the current status of coding management of drug production sites in foreign countries, the coding management of production sites in industries such as shipping and food, and the management of drug production sites in China, etc. Results and Conclusion: This article puts forward suggestions from the perspectives of system guarantee, coding granularity, and social cogovernance to provide reference for the coding management of the drug production sites in China.

Objective: This article has sorted out, summarized and analyzed relevant regulations and technical documents on registration management of in vitro diagnostic reagents, which is helpful for practitioners and supervisors to fully grasp the key links and supporting requirements of the registration system, improve the scientifi c and accurate supervision of in vitro diagnostic reagent products, and improve the effi ciency and quality of enterprise product registration. Methods: From the perspective of changes in supervision and management, this paper interpreted the product classification rules, implementation standards, clinical evaluation, review guidelines, special approval procedures and other regulatory contents, analyzed the prospects and problems faced by the IVD reagent industry, and explained the significant effects of the revised regulations on ensuring the safety, eff ectiveness and quality control of IVD reagents. Results and Conclusion: Through the revision of IVD product registration and management regulations, the adjustment of classifi cation rules was realized, and some problems such as the mismatch between the classifi cation of some products and their risks were solved. Improve the implementation of product standards, play the technical support role of standards; implementing the main responsibility of enterprises, strengthening the management of clinical trials, issuing guidelines for review, and supplementing special approval conditions have played a signifi cant role in ensuring the safety, eff ectiveness and quality control of IVD reagents, and have a far-reaching impact on the development of the overall industry of in vitro diagnostic reagents.

Objective: In order to provide references for the selection of reference medical products before the development of generic drugs in China, this paper introduces the latest content of “Evaluation of Therapeutic Equivalence Guidance for Industry” in the United States, and sorts out the factors to consider the equivalence of generic drugs and original drugs treatments. Methods: By introducing the equivalence categories of multi-source prescription drugs approved under the Federal Food, Drug, and Cosmetics Act (FD&C Act) and the labeling of equivalent drugs in the US drug orange book, the identifi cation principle and dynamic management mode of the equivalence evaluation system in the U.S. FDA Orange Book, were analyzed in order to provide ideas for the determination and management of reference medical products of generic drugs in China. Results and Conclusion: Judgment principle of therapeutic equivalence of chemical generic drugs in the United States and using the therapeutic equivalence code in the Orange Book, it provides reference for the selection, therapeutic equivalence evaluation and management mode of reference medical products in the development of chemical generic drugs in China.

Objective: This paper reviews and analyzes the practice of global drug regulatory cooperation and the internationalization process of drug regulation in China, and makes suggestions for China to join the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as soon as possible to achieve mutual recognition in GMP inspection. Methods: According to the requirements of PIC/S for applicant authorities, in order to prepare for the evaluation of China's drug inspection authorities by PIC/S, this paper analyzes the current gaps in China's drug inspection system based on literature review, inspection status analysis and interpretation of PIC/S audit checklist indicators. Results and Conclusion: Joining PIC/S will help strengthen cooperation between regulatory authorities in various countries and achieve mutual recognition in GMP inspection, and further promote the internationalization of drug regulation in China. In order to successfully pass the formal evaluation of China's drug inspection authorities by PIC/S and become a member authority of PIC/S as soon as possible, China should carry out benchmarking work as early as possible in terms of improving GMP standards, optimizing inspection processes, improving inspector capabilities, and building quality systems for inspection authorities.

Objective: To analyze the problems in off -label drug use (OLDU) regulation in China and provide feasible suggestions for improving the regulatory system, with the aim of reducing the risk of OLDU and improving the level of rational drug use. Methods: By reviewing the literature and regulations, the regulatory framework and core mechanism of OLDU in France were analyzed, and the existing problems and improvement paths of OLDU regulation in China were compared and researched. Results: France has established a sound regulatory framework at the legal level, and has ensured the regulation and safety of the use of OLDU through multiple assessments, patient protection, continuous monitoring and evaluation, and information disclosure mechanism. Conclusion: Chinese regulatory system of OLDU is still imperfect and lack of implementation standards at the regulatory level. It is suggested that China should strengthen the construction in the legal system, patient protection and information disclosure to clarify the use requirements and standards for OLDU, so as to reduce the risk of OLDU and protect the legitimate rights and interests of doctors and patients.

Objective: To provide references for China to improve provincial drug sampling and testing activities (DSTA), and further explore the national and provincial DSTA mode. This paper studies the post-marketing surveillance strategy of Decentralized Procedure and Mutual Recognition Procedure (DCP/MRP) for drugs in the EU. Methods: Using the literature research method, the relevant regulatory framework, procedural documents and other information related to post-marketing surveillance of DCP/MRP in the EU were summarized, and key measures were discussed and analyzed. Results: The EU has established a risk assessment institutional framework and general principles, formed a plan management model based on the mutual evaluation system, formulated a special quality control system for the inspection collaboration network, built a single-point collaborative counterfeit and inferior drug control platform and a diversifi ed and open transformation and application chain. Conclusion: The study of the key measures taken by the EU DCP/MRP post-marketing surveillance has certain reference value for improving the provincial drug sampling and testing management in China.

Objective: To describe the signifi cant changes in the requirements and connection of drug registration testing initiation work at the current stage, so as to provide reference for the continuous promotion and improvement of the registration testing initiation work under the new form of drug review and approval reform. Methods: This article introduces the implementation of the initiation of drug registration testing work in detail from the policy change process, the specific work requirements, the situation and process of drug registration testing initiation, and the connection with the drug testing agency. Results and Conclusion: In order to further promote the implementation of the relevant requirements for the registration testing initiation work and improve the work quality and effi ciency, the actual existing problems were analyzed and discussed. The implementation of the main responsibilities of the applicant should be strengthened, the starting situation and process of drug registration testing should be optimized, and the connection procedure between drug technical review and registration testing work should be improved.

Objective: To explore the relationship between the regulations of COVID-19 in-vitro diagnostic (IVD) reagents and public health practices, summarize the experience of fi ghting the COVID-19 from a regulatory science perspective and provide reference for continually improving the emergency regulation system. Methods: The approval procedures, requirements and product data of different countries/organizations and the reasons for differences were analyzed. Results and Conclusion: The supervisions of these IVD products in different countries/organizations are consistent with the diff erent conditions especially the context diff erences of product application. The supervision of IVD reagents in China is closely related to public health policies and has played a positive role in fi ghting against COVID-19.