Objective: To sort out the current situation and defi ciencies of emergency management of medicine and equipment in my country in response to the Corona Virus Disease 2019 infection, put forward the suggestions and enlightenment of emergency management of medicine and equipment for public health emergencies under the new situation, and improve the level of emergency management of medical equipment. Methods: The emergency management of medicine and equipment in the prevention and control of the new crown epidemic was reviewed by means of literature review, supplemented and improved through interviews and investigations, and the weak points in the response were studied. Results: Relevant departments have taken active measures to deal with the safeguard, whereas there were still defi ciencies in the construction of laws and regulations, the planning system, the review mechanism and other aspects. Conclusion: The emergency management of pharmaceutical equipment in our country should further improve the legislation, optimize the emergency system, establish a decision-making platform, strengthen emergency technical reserves, and scientifi cally carry out emergency training exercises.

Objective: To analyze the main problems to be solved in the management of drug clinical trial contracts and put forward corresponding countermeasures and suggestions in order to prevent the possible risks of drug clinical trials. Methods: The relevant literature, laws, regulations and rules were consulted, and the clinical drug trial contracts were analyzed and studied in combination with the status quo of clinical drug trials and the contract management of clinical drug trial institutions in our country. Results: The contract subject, contract form and contents covered by the contract include subjects' compensation for damages, trial costs, breach of contract and termination, application of law and jurisdiction, etc., which are the main issues in clinical trial contracts and the important links of drug clinical trial management. Conclusion: Clinical trial contracts can be managed in a scientific and standardized way only by establishing a reasonable review mechanism, strengthening the construction of review team and paying attention to the clauses prone to problems or controversial clauses.

Objective: This paper aims to clarify the major changes of radiopharmaceuticals regulatory regulations after the implementation of the new version “Pharmaceutical Administration Law of the People's Republic of China” (Hereinafter referred to as the “Pharmaceutical Administration Law”), so as to provide reference for radiopharmaceuticals regulatory and radiopharmaceuticals related enterprises. Methods: According to the new requirements of provisions for drug registration, drug production supervision and administration measures, radiopharmaceuticals administration measures and related systems, the main changes affecting the supervision and administration of radiopharmaceuticals were summarized and analyzed. Results and Conclusions: The new version of The “Pharmaceutical Administration Law” implemented the people-oriented concept, strengthened the supervision of the whole life cycle of radioactive drugs, and at the same time aroused the enthusiasm of the radioactive drugs market, promoted the management ability and the implementation of the main responsibility of the marketing authorization holders.

Objective: By analyzing the relevant policy texts on traditional Chinese medicine traceability system in China, this study discusses the current policy status and development tendency, which is aims to provide reference for formulation and optimization of traditional Chinese medicine traceability system policy in the future. Methods: Using the content analysis method, 29 policies related to traditional Chinese medicine traceability system were selected as research objects based on the two dimensions of policy tools and stakeholders. Results: In the dimension of policy tools, command and regulation, incentive, capacity building, system transformation, information and exhortation tools account for 51.7%, 12.2%, 22.0%, 1.0% and 13.2% respectively. In the dimension of stakeholders, relevant government departments, TCM production manufacturers, TCM distributors, medical institutions and consumers accounted for 45.2%, 21.5%, 21.5%, 6.3% and 5.6% respectively. Conclusion: The structure of policy tools is unbalanced, the use of internal policy tools is uncoordinated and the distribution of stakeholder is uneven. We should combine the relevant policy characteristics and development trends of the traditional Chinese medicine traceability system, use policy tools in a diversifi ed way, optimize its internal structure, take into account all stakeholders, and enhance the cohesion of the main body.

Objective: To provide suggestions for perfecting the vaccine on-site inspection system. Methods: Based on our own on-site inspection practice, this paper compares the implementation of the vaccine on-site inspection system of the relevant provincial medical administration, analyzes the problems it faced, and puts forward the corresponding suggestions. Results and Conclusion: The system faces many practical diffi culties, such as the great pressure of lifelong accountability, the limited professional ability of inspectors, and the paradox of information advantages. The paper suggests to clarify the system positioning, give full play to the advantages of "on-site", develop the GMP compliance inspection system in dislocation, optimize the on-site mode and inspection scheme, and focus on risk signals.