OBJECTIVE To provide references and recommendations for improving the regulatory framework for cell and gene therapy products and treatments in China. METHODS This study systematically examined the “dual-track regulatory” frameworks for regenerative medicine products and treatments in Japan and the Republic of Korea， summarized their beneficial experiences， and explored optimization strategies for China’s regulatory practices. RESULTS & CONCLUSIONS Both Japan and the Republic of Korea have established clear management processes for two distinct pathways “registered clinical trials for regenerative medicine products” and “clinical research on regenerative medicine treatments” guided by shared principles of “risk stratification” and “full lifecycle oversight”. Based on these findings， it is recommended that China： strengthen top-tier legislative framework to explicitly delineate the regulatory scope governing cell and gene therapy products and treatments； clarify the jurisdictional responsibilities of relevant regulatory bodies to enhance oversight efficacy； appropriately calibrate the regulatory scope， and adopt a balanced regulatory approach that harmonizes standardization with innovation incentives， thereby accelerating the clinical translation of regenerative medicine products.

Objective To assess inter-observer variations(IOV)in the delineation of target volumes and organs-at-risk(OAR)for intensity-modulated radiotherapy(IMRT)of nasopharyngeal carcinoma(NPC)among physicians from different levels of cancer centers,thereby providing a reference for quality control in multi-center clinical trials.Methods Twelve patients with NPC of different TMN stages were randomly selected.Three physicians from the same municipal cancer center manually delineated the target volume(GTVnx)and OAR for each patient.The manually modified and confirmed target volume(GTVnx)and OAR delineation structures by radiotherapy experts from the regional cancer center were used as the standard delineation.The absolute volume difference ratio(△V_diff),maximum/minimum volume ratio(MMR),coefficient of variation(CV),and Dice similarity coefficient(DSC)were used to compare the differences in organ delineation among physicians from different levels of cancer centers and among the 3 physicians from the same municipal cancer center.Furthermore,the IOV of GTVnx and OAR among physicians from different levels cancer centers were compared across different TMN stages.Results Significant differences in the delineation of GTVnx were observed among physicians from different levels of cancer centers.Among the 3 physicians,the maximum values of △V_diff,MMR,and CV were 97.23%±83.45%,2.19±0.75,and 0.31±0.14,respectively,with an average DSC of less than 0.7.Additionally,there were considerable differences in the delineation of small-volume OAR such as the left and right optic nerves,chiasm,and pituitary,with average MMR>2.8,CV>0.37,and DSC<0.51.However,relatively smaller differences were observed in the delineation of large-volume OAR such as the brainstem,spinal cord,left and right eyeballs,and left and right mandible,with average△V_diff<42%,MMR<1.55,and DSC>0.7.Compared with the differences among physicians from different levels cancer centers,the differences among the 3 physicians from the municipal cancer center were slightly reduced.Furthermore,there were also differences in the delineation of target volumes for NPC among physicians from different levels cancer centers,depending on the staging of the disease.Compared with the delineation of target volumes for earlier stage patients(stages I or II),the differences among physicians in the delineation of target volumes for advanced stage patients(stages III or IV)were smaller,with average △V_diff and DSC of 98.31%±67.36%vs 69.38%±72.61%(P<0.05)and 0.55±0.08 vs 0.72±0.12(P<0.05),respectively.Conclusion There are differences in the delineation of GTVnx and OAR in radiation therapy for NPC among physicians from different levels of cancer centers,especially in the delineation of target volume(GTVnx)and small-volume OAR for early-stage patients.To ensure the accuracy of multicenter clinical trials,it is recommended to provide unified training to physicians from different levels of cancer centers and review their delineation results to reduce the effect of differences on treatment outcomes.

Objective:It aims to evaluate the impact of National Pharmaceutical Centralized Purchase(NPCP)and continuation policies on drug utilization,pricing,and expenditure,providing insights for optimizing national procurement strategies.Methods:Using descriptive statistics,a statistical analysis was conducted to examine changes in drug procurement amounts,Defined Daily Doses(DDDs),Defined Daily Dose cost(DDDc),and generic drug substitution rates pre-and post-implementation of the NPCP and continuation policies in hospitals and pharmacies across four municipalities.Results:The policy successfully achieved its goals of streamlining procurement processes,reducing drug prices,and promoting generic drug substitution.However,a notable trend of originator drug diversion to the retail sector was observed,indicating lingering patient reservations towards generics.Conclusion:It is needed to clarty the relation ship between NPCP continous policy and the medical insurance payment standard decision,strengthen the real-world evaluation on selected drug efficacy and safety,enhance the publicity on rated generic drugs,and promote the acceptance of public awareness.

Objective:It aims to evaluate the impact of National Pharmaceutical Centralized Purchase(NPCP)and continuation policies on drug utilization,pricing,and expenditure,providing insights for optimizing national procurement strategies.Methods:Using descriptive statistics,a statistical analysis was conducted to examine changes in drug procurement amounts,Defined Daily Doses(DDDs),Defined Daily Dose cost(DDDc),and generic drug substitution rates pre-and post-implementation of the NPCP and continuation policies in hospitals and pharmacies across four municipalities.Results:The policy successfully achieved its goals of streamlining procurement processes,reducing drug prices,and promoting generic drug substitution.However,a notable trend of originator drug diversion to the retail sector was observed,indicating lingering patient reservations towards generics.Conclusion:It is needed to clarty the relation ship between NPCP continous policy and the medical insurance payment standard decision,strengthen the real-world evaluation on selected drug efficacy and safety,enhance the publicity on rated generic drugs,and promote the acceptance of public awareness.

Objective:It aims to evaluate the impact of National Pharmaceutical Centralized Purchase(NPCP)and continuation policies on drug utilization,pricing,and expenditure,providing insights for optimizing national procurement strategies.Methods:Using descriptive statistics,a statistical analysis was conducted to examine changes in drug procurement amounts,Defined Daily Doses(DDDs),Defined Daily Dose cost(DDDc),and generic drug substitution rates pre-and post-implementation of the NPCP and continuation policies in hospitals and pharmacies across four municipalities.Results:The policy successfully achieved its goals of streamlining procurement processes,reducing drug prices,and promoting generic drug substitution.However,a notable trend of originator drug diversion to the retail sector was observed,indicating lingering patient reservations towards generics.Conclusion:It is needed to clarty the relation ship between NPCP continous policy and the medical insurance payment standard decision,strengthen the real-world evaluation on selected drug efficacy and safety,enhance the publicity on rated generic drugs,and promote the acceptance of public awareness.

Objective:It aims to evaluate the impact of National Pharmaceutical Centralized Purchase(NPCP)and continuation policies on drug utilization,pricing,and expenditure,providing insights for optimizing national procurement strategies.Methods:Using descriptive statistics,a statistical analysis was conducted to examine changes in drug procurement amounts,Defined Daily Doses(DDDs),Defined Daily Dose cost(DDDc),and generic drug substitution rates pre-and post-implementation of the NPCP and continuation policies in hospitals and pharmacies across four municipalities.Results:The policy successfully achieved its goals of streamlining procurement processes,reducing drug prices,and promoting generic drug substitution.However,a notable trend of originator drug diversion to the retail sector was observed,indicating lingering patient reservations towards generics.Conclusion:It is needed to clarty the relation ship between NPCP continous policy and the medical insurance payment standard decision,strengthen the real-world evaluation on selected drug efficacy and safety,enhance the publicity on rated generic drugs,and promote the acceptance of public awareness.

Objective:It aims to evaluate the impact of National Pharmaceutical Centralized Purchase(NPCP)and continuation policies on drug utilization,pricing,and expenditure,providing insights for optimizing national procurement strategies.Methods:Using descriptive statistics,a statistical analysis was conducted to examine changes in drug procurement amounts,Defined Daily Doses(DDDs),Defined Daily Dose cost(DDDc),and generic drug substitution rates pre-and post-implementation of the NPCP and continuation policies in hospitals and pharmacies across four municipalities.Results:The policy successfully achieved its goals of streamlining procurement processes,reducing drug prices,and promoting generic drug substitution.However,a notable trend of originator drug diversion to the retail sector was observed,indicating lingering patient reservations towards generics.Conclusion:It is needed to clarty the relation ship between NPCP continous policy and the medical insurance payment standard decision,strengthen the real-world evaluation on selected drug efficacy and safety,enhance the publicity on rated generic drugs,and promote the acceptance of public awareness.

Objective:It aims to evaluate the impact of National Pharmaceutical Centralized Purchase(NPCP)and continuation policies on drug utilization,pricing,and expenditure,providing insights for optimizing national procurement strategies.Methods:Using descriptive statistics,a statistical analysis was conducted to examine changes in drug procurement amounts,Defined Daily Doses(DDDs),Defined Daily Dose cost(DDDc),and generic drug substitution rates pre-and post-implementation of the NPCP and continuation policies in hospitals and pharmacies across four municipalities.Results:The policy successfully achieved its goals of streamlining procurement processes,reducing drug prices,and promoting generic drug substitution.However,a notable trend of originator drug diversion to the retail sector was observed,indicating lingering patient reservations towards generics.Conclusion:It is needed to clarty the relation ship between NPCP continous policy and the medical insurance payment standard decision,strengthen the real-world evaluation on selected drug efficacy and safety,enhance the publicity on rated generic drugs,and promote the acceptance of public awareness.

Objective:It aims to evaluate the impact of National Pharmaceutical Centralized Purchase(NPCP)and continuation policies on drug utilization,pricing,and expenditure,providing insights for optimizing national procurement strategies.Methods:Using descriptive statistics,a statistical analysis was conducted to examine changes in drug procurement amounts,Defined Daily Doses(DDDs),Defined Daily Dose cost(DDDc),and generic drug substitution rates pre-and post-implementation of the NPCP and continuation policies in hospitals and pharmacies across four municipalities.Results:The policy successfully achieved its goals of streamlining procurement processes,reducing drug prices,and promoting generic drug substitution.However,a notable trend of originator drug diversion to the retail sector was observed,indicating lingering patient reservations towards generics.Conclusion:It is needed to clarty the relation ship between NPCP continous policy and the medical insurance payment standard decision,strengthen the real-world evaluation on selected drug efficacy and safety,enhance the publicity on rated generic drugs,and promote the acceptance of public awareness.

Objective:It aims to evaluate the impact of National Pharmaceutical Centralized Purchase(NPCP)and continuation policies on drug utilization,pricing,and expenditure,providing insights for optimizing national procurement strategies.Methods:Using descriptive statistics,a statistical analysis was conducted to examine changes in drug procurement amounts,Defined Daily Doses(DDDs),Defined Daily Dose cost(DDDc),and generic drug substitution rates pre-and post-implementation of the NPCP and continuation policies in hospitals and pharmacies across four municipalities.Results:The policy successfully achieved its goals of streamlining procurement processes,reducing drug prices,and promoting generic drug substitution.However,a notable trend of originator drug diversion to the retail sector was observed,indicating lingering patient reservations towards generics.Conclusion:It is needed to clarty the relation ship between NPCP continous policy and the medical insurance payment standard decision,strengthen the real-world evaluation on selected drug efficacy and safety,enhance the publicity on rated generic drugs,and promote the acceptance of public awareness.