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: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.

The pricing and reimbursement of orphan drugs are related to the accessibility of patients,and are of great significance to the prevention and guarantee of rare diseases.European countries have formed special standards and paths for health technology evaluation,and established special payment funds and diversified risk-sharing agreements,which have effectively improved the accessibility of orphan drugs.Based on this,it selected typical European countries to compare the orphan drug pricing and reimbursement methods.Then,it put forward some suggestions"building orphan drug health technology evaluation accelerated program,exploring the health of orphan drug classification security mechanism,and attaining supply incentives and development incentives through orphan drug pricing and adjustment",to optimize the basis for the orphan drug market access mechanism to provide reference.

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.