Objective To study the influence of national drug centralized procurement policy on pharmaceutical enterprises manufacturing generic drugs and original drugs,so as to provide a reference for them to make different str...Objective To study the influence of national drug centralized procurement policy on pharmaceutical enterprises manufacturing generic drugs and original drugs,so as to provide a reference for them to make different strategic choices.Methods Through the literature research on the related policies and the bidding data,the national drug centralized policies were studied systematically.Combined with the bid-winning price and price reduction range of the winning enterprises in the three rounds of centralized procurement,their difficulties,strategic choices and the winning factors were investigated.Besides,a model was established to clarify the optimal price of enterprises in the process of drug procurement.Results and Conclusion The strategic choices of enterprises in participating national drug centralized procurement are influenced by many factors such as the market share of the original varieties,active pharmaceutical ingredients(APIs)and cost.Therefore,corresponding strategies should be formulated according to the characteristics and interests of enterprises.展开更多
Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dos...Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dosage forms and specifications on the same line to save costs in China.Methods The application status of quality risk management in the production of drugs was analyzed by consulting literature,field investigation and research re-lated policies.Results and Conclusion When introducing co-line products,we should focus on combining prod-uct reality,establish a cross-professional team in comprehensive quality,R&D,equipment,and production.Then we can coordinate quality risk management to integrate with each other to avoid“shortcomings”in different links,which will affect the effectiveness of risk management.When a company conducts co-line production,it should rely on quality risk management theories to establish a scientific quality management system,reasonably use qual-ity risk assessment tools to evaluate the types of co-line production,and control key risk factors effectively.These methods can ensure the risk of co-production within an acceptable range.展开更多
文摘Objective To study the influence of national drug centralized procurement policy on pharmaceutical enterprises manufacturing generic drugs and original drugs,so as to provide a reference for them to make different strategic choices.Methods Through the literature research on the related policies and the bidding data,the national drug centralized policies were studied systematically.Combined with the bid-winning price and price reduction range of the winning enterprises in the three rounds of centralized procurement,their difficulties,strategic choices and the winning factors were investigated.Besides,a model was established to clarify the optimal price of enterprises in the process of drug procurement.Results and Conclusion The strategic choices of enterprises in participating national drug centralized procurement are influenced by many factors such as the market share of the original varieties,active pharmaceutical ingredients(APIs)and cost.Therefore,corresponding strategies should be formulated according to the characteristics and interests of enterprises.
文摘Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dosage forms and specifications on the same line to save costs in China.Methods The application status of quality risk management in the production of drugs was analyzed by consulting literature,field investigation and research re-lated policies.Results and Conclusion When introducing co-line products,we should focus on combining prod-uct reality,establish a cross-professional team in comprehensive quality,R&D,equipment,and production.Then we can coordinate quality risk management to integrate with each other to avoid“shortcomings”in different links,which will affect the effectiveness of risk management.When a company conducts co-line production,it should rely on quality risk management theories to establish a scientific quality management system,reasonably use qual-ity risk assessment tools to evaluate the types of co-line production,and control key risk factors effectively.These methods can ensure the risk of co-production within an acceptable range.
