The legal and regulatory system for the import of blood products in China has undergone a three-stage evolution of"safety first,demand-driven and standard upgrading",ultimately forming a dual control framework that centers on infectious disease prevention and control as well as quality approval.While the current policy effectively ensures biosafety,it also faces several deep-seated contradictions.These include the worsening imbalance between supply and demand,limited access to clinically needed blood products,and insufficient alignment with international standards.Moreover,strict regulation has also constrained technological innovation and market diversification.To address these challenges,it is suggested to establish a synergy mechanism that integrates a"clinical urgent need list,"hierarchical supervision,and mutual recognition of Good Manufacturing Practice(GMP).By implementing dynamic access,risk classification management,and international certification mutual recognition,it is possible to achieve compatible development between the safety baseline and medical accessibility.

Blood products play a pivotal role in modern medical treatment and healthcare system,and the clinical demand in China continues to grow.However,there is a significant supply gap for raw plasma domestically,with over 60％of human albumin relying on imports.The regulatory framework for imported blood products in China has undergone multiple rounds of adjustments,establishing a comprehensive lifecycle oversight system centered around the《Law of the People's Republic of China on the Administration of Drugs》and the《Measures for the Administration of Batch Release of Biological Products》.While ensuring safety,this framework has also led to issues such as insufficient clinical supply and elevated corporate costs because of stringent market access requirements,complex approval procedures,and tariff barriers.Specifically,import market access barriers have imposed a'dual-certification'burden,and tariff barriers have increased the costs of some products,exacerbating the financial burden on patients.In response to these challenges,it is recommended to establish an interdepartmental information-sharing platform,promote mutual recognition of international quality standards,form a rapid approval team for urgently needed medications,and reduce or exempt tariffs for clinically critical products.

The legal and regulatory system for the import of blood products in China has undergone a three-stage evolution of"safety first,demand-driven and standard upgrading",ultimately forming a dual control framework that centers on infectious disease prevention and control as well as quality approval.While the current policy effectively ensures biosafety,it also faces several deep-seated contradictions.These include the worsening imbalance between supply and demand,limited access to clinically needed blood products,and insufficient alignment with international standards.Moreover,strict regulation has also constrained technological innovation and market diversification.To address these challenges,it is suggested to establish a synergy mechanism that integrates a"clinical urgent need list,"hierarchical supervision,and mutual recognition of Good Manufacturing Practice(GMP).By implementing dynamic access,risk classification management,and international certification mutual recognition,it is possible to achieve compatible development between the safety baseline and medical accessibility.

Blood products play a pivotal role in modern medical treatment and healthcare system,and the clinical demand in China continues to grow.However,there is a significant supply gap for raw plasma domestically,with over 60％of human albumin relying on imports.The regulatory framework for imported blood products in China has undergone multiple rounds of adjustments,establishing a comprehensive lifecycle oversight system centered around the《Law of the People's Republic of China on the Administration of Drugs》and the《Measures for the Administration of Batch Release of Biological Products》.While ensuring safety,this framework has also led to issues such as insufficient clinical supply and elevated corporate costs because of stringent market access requirements,complex approval procedures,and tariff barriers.Specifically,import market access barriers have imposed a'dual-certification'burden,and tariff barriers have increased the costs of some products,exacerbating the financial burden on patients.In response to these challenges,it is recommended to establish an interdepartmental information-sharing platform,promote mutual recognition of international quality standards,form a rapid approval team for urgently needed medications,and reduce or exempt tariffs for clinically critical products.