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.

In this study,the similarities and differences of plasma collection and quality control in China and abroad were analyzed by comparing the related regulations,standards,guidelines and literatures.Rational and constructive suggestions were proposed,aiming to optimize domestic plasma management and promote the improvement of plasma-related standards.There was little difference on facilities and safety control process of plasma between China and the developed countries(United States,EU and Japan),However,significant differences existed on plasma station setting,donor screening standards,collection interval,volume limits,plasma testing modes and tests,plasma quarantine standard and utilization of recovered plasma.The United States sets the industry benchmark and is worthy of reference for our country both in plasma collection and quality control.

The blood products industry,both domestically and internationally,exhibits distinct features in product research,development,and technological innovation.International companies possess extensive expertise in developing immunoglobulins,coagulation factors,and recombinant plasma protein products,demonstrating continuous advancements-particularly in specific immunoglobulin development,long-acting formulation optimization,and manufacturing process improvements.In recent years,Chinese enterprises have also achieved notable progress in related fields,especially in immunoglobulin process refinement and the development of novel recombinant coagulation factor products.However,there remains significant scope for improvement in areas such as the application of recombinant protein technologies,efficient utilization of plasma resources,and the adoption of advanced manufacturing techniques.Additional challenges include the accumulation of patented technologies,the supply of critical raw materials,and access to comprehensive epidemiological data.Driven by ongoing advances in gene recombination technologies,innovations in drug delivery systems,digital transformation,and the rise of personalized medicine,the blood products industry is poised for broader development prospects.To foster sustained and stable domestic industry growth and enhance global competitiveness,Chinese blood product enterprises should intensify their technological accumulation,upgrade manufacturing processes,and optimize plasma resource utilization.

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.

In this study,the similarities and differences of plasma collection and quality control in China and abroad were analyzed by comparing the related regulations,standards,guidelines and literatures.Rational and constructive suggestions were proposed,aiming to optimize domestic plasma management and promote the improvement of plasma-related standards.There was little difference on facilities and safety control process of plasma between China and the developed countries(United States,EU and Japan),However,significant differences existed on plasma station setting,donor screening standards,collection interval,volume limits,plasma testing modes and tests,plasma quarantine standard and utilization of recovered plasma.The United States sets the industry benchmark and is worthy of reference for our country both in plasma collection and quality control.

The blood products industry,both domestically and internationally,exhibits distinct features in product research,development,and technological innovation.International companies possess extensive expertise in developing immunoglobulins,coagulation factors,and recombinant plasma protein products,demonstrating continuous advancements-particularly in specific immunoglobulin development,long-acting formulation optimization,and manufacturing process improvements.In recent years,Chinese enterprises have also achieved notable progress in related fields,especially in immunoglobulin process refinement and the development of novel recombinant coagulation factor products.However,there remains significant scope for improvement in areas such as the application of recombinant protein technologies,efficient utilization of plasma resources,and the adoption of advanced manufacturing techniques.Additional challenges include the accumulation of patented technologies,the supply of critical raw materials,and access to comprehensive epidemiological data.Driven by ongoing advances in gene recombination technologies,innovations in drug delivery systems,digital transformation,and the rise of personalized medicine,the blood products industry is poised for broader development prospects.To foster sustained and stable domestic industry growth and enhance global competitiveness,Chinese blood product enterprises should intensify their technological accumulation,upgrade manufacturing processes,and optimize plasma resource utilization.

Objective To analyze the blood concentration monitoring results of 7 new antiepileptic drugs levetiracetam(LEV),oxcarbazepine(OXC),lamotrigine(LTG),topiramate(TPM),lacosamide(LCM),zonisamide(ZNS)and perampanel(PER)and provide a basis for clinical rational drug use.Methods Aretrospective analysis was conducted on the blood concentration monitoring results of 7 new antiepileptic drugs in a grade-A tertiary hospital in Beijing from November 2021 to March 2023,with a total of 6 537 valid concentration data collected.The patients were grouped according to age,gender and concomitant medication,and the blood drug concentration levels and compliance rates among the groups were analyzed and compared.Results The male to female patient ratio was 1.35∶1.There were statistically significant differences in the blood concentration distribution of OXC,LEV,LCM and TPM between genders(P<0.05).The blood concentration of LEV showed statistically significant differences between the pediatric group and the elderly group,as well as between the young adult group and the elderly group(P<0.05).The blood concentrations of OXC,ZNS and TPM showed statistically significant differences between the pediatric group and the young and middle-aged group,between the young and middle-aged group and the elderly group,and between the pediatric group and the young and middle-aged group,respectively(P<0.05).The highest and lowest overall compliance rates of blood concentration were observed for OXC and LCM,respectively.The compliance rates of OXC and TPM in the pediatric group were significantly higher than those in the young-middle-aged group,with statistically significant differences(P<0.05),while the compliance rate of LEV in the elderly group was significantly higher than that in the pediatric group and the young-middle-aged group,with a statistically significant difference(P<0.05).There were a total of 2 133 cases with combined drug use.LEV,OXC and LTG are frequently used and have good efficacy and weak interactions when added to treatment.Conclusion New antiepileptic drugs show a promising prospect in treatment,and therapeutic drug monitoring can further improve the effectiveness of individualized clinical treatment.

Objective:To investigate the effect of drug metabolism related gene polymorphism on the efficacy of clopidogrel in patients with acute coronary syndrome (ACS).Methods:The medical records and follow-up records of ACS patients, who were hospitalized in the People′s Hospital of Daxing District between 2017 and 2019, received standardized treatment with aspirin (100 mg/day)+clopidogrel (75 mg/day), and underwent testing for genetic polymorphisms related to clopidogrel absorption/metabolism, were collected. The patients were divided into thrombotic event group and non-thrombotic event group according to whether they experienced thrombotic events such as myocardial infarction, stent thrombosis, and cerebral infarction within 1 year of treatment. The age, gender, smoking history and drinking habits, underlying diseases, drug combination, and alleles related to clopidogrel absorption/metabolism in patients in the 2 groups were compared. The factors affecting the clinical efficacy of clopidogrel was analyzed using logistic regression model.Results:A total of 342 patients were included in the analysis, including 274 males and 68 females, aged (58±9) years; of them, 78 (22.8%) developed thrombotic events. The differences in age, gender, smoking history, drinking history, hypertension, diabetes mellitus, hyperlipidemia, percutaneous coronary intervention history, proportion of combined with calcium channel antagonists, cytochrome P450 (CYP) 2C19*3, paraoxonase-1 Q192R, and adenosine triphosphate binding cassette transporter B1 C3435T between the thrombotic event group and the non-thrombotic event group were not statistically significant (all P>0.05), but the body mass index (BMI), the proportion of CYP2C19*2 GG type and CYP2C19*17 CT type in patients in the thrombotic event group were lower than those in the non-thrombotic event group (all P<0.05), and the proportion of patients with proton pump inhibitor and CYP2C19*17 CC type in the thrombotic event group was higher than that in the non-thrombotic event group (all P<0.05). Multivariate logistic regression analysis showed that high BMI ( OR=0.915, 95 %CI: 0.847-0.989, P=0.026), CYP2C19*2 GG type ( OR=0, 95 %CI: 0-0.008, P<0.001), and GA type ( OR=0.028, 95 %CI: 0.003-0.296, P=0.003) were independent protective factors for thrombotic events after clopidogrel treatment; CYP2C19*17 CC type ( OR=2 856.665, 95 %CI: 87.337-93 436.810, P<0.001) was an independent risk factor for thrombotic events after clopidogrel treatment. Conclusion:CYP2C19*2 and CYP2C19*17 mutations are important factors affecting the efficacy of clopidogrel and the occurrence of thrombotic events after treatment in ACS patients.