Historically,"big pharma"did most central nervous system drug discovery R&D in-house.Yet,in modern times their"management reductionism"resulted in disappointing pipelines and pharma resided to(...Historically,"big pharma"did most central nervous system drug discovery R&D in-house.Yet,in modern times their"management reductionism"resulted in disappointing pipelines and pharma resided to(late)development,regulatory approval,and marketing(Thong,2015).This had significant consequences for financing and executing research,resulting in a larger role for funding by governments and patient-organizations and a shift of research to academia(Mazzucato,2013).展开更多
State Administration for Market Regulation and National Standardization Administration of China have approved the following 278 voluntary national standards and 3 voluntary national standards with amendment.
Objective To put forward some suggestions for improving the registration and regulation,the efficiency of evaluation,and approval of biosimilar in China so as to promote the development of biopharmaceutical industry a...Objective To put forward some suggestions for improving the registration and regulation,the efficiency of evaluation,and approval of biosimilar in China so as to promote the development of biopharmaceutical industry and increase the accessibility of therapeutic drugs in China.Methods Literature related to the registration and regulation,evaluation and approval of biosimilars were sorted out to analyze the differences in China and the USA.Results and Conclusion Based on the analysis of the current situation of registration and regulation of biosimilars between China and the USA,it is suggested to improve the registration and regulation of biosimilars in China from the following four aspects:Establishing a biosimilar regulatory department,expanding the professional evaluation personnel,scientifically simplifying the registration and approval procedures,and constantly refining the types of communication meetings.展开更多
State Administration for Market Regulation and National Standardization Administration of China have approved the following 416 voluntary national standards and 3 voluntary national standards with amendment.
To the Editor:Immune checkpoint inhibitors(ICIs)interact with critical factors involved in immunoregulation.Following the FDA approval of nivolumab as a second line therapy for unresectable hepatocellular carcinoma(HC...To the Editor:Immune checkpoint inhibitors(ICIs)interact with critical factors involved in immunoregulation.Following the FDA approval of nivolumab as a second line therapy for unresectable hepatocellular carcinoma(HCC)in 2017,numerous HCC patients have experienced benefits from ICIs[1].In 2020,the FDA approved the combination of atezolizumab and bevacizumab as first line treatment for unresectable HCCs that have not undergone prior systemic treatments[2].ICIs are driving a transformative change in the field of cancer therapy.展开更多
Ethical approval is the first essential step for medical master’s students to officially initiate research.This article discusses the ethical issues encountered in various types of research projects conducted by prof...Ethical approval is the first essential step for medical master’s students to officially initiate research.This article discusses the ethical issues encountered in various types of research projects conducted by professional master’s students,the preparation of ethical application materials,conflicts between the timing of ethical applications and the clinical training rotation schedules,and the continuity of ethical applications among students within the same cohort and across different cohorts.展开更多
State Administration for Market Regulation and National Standardization Administration of China have approved the following 12 national standards and 3 national standards with amendment.
State Administration for Market Regulation and National Standardization Administration of China have approved the following 10 national standards and 1 national standard with amendment.
Ministry:Rare earth export applications approved China has been approving all compliant rare earth export applications for civilian use without delay,the Ministry of Commerce said on Dec.4,2025.This comes after a surv...Ministry:Rare earth export applications approved China has been approving all compliant rare earth export applications for civilian use without delay,the Ministry of Commerce said on Dec.4,2025.This comes after a survey claimed that several European businesses were already,or expecting to be,affected by China's export controls.展开更多
State Administration for Market Regulation and National Standardization Administration of China have approved the foreign language versions of the following 79 national standards.
The digital economy has become an important impetus of global economic growth. The rapid development of emerging and key technological fields, such as the new generation of information technology and biotechnology, ha...The digital economy has become an important impetus of global economic growth. The rapid development of emerging and key technological fields, such as the new generation of information technology and biotechnology, has put forward new requirements for standards development.However, the traditional mode of standards development relying on paper documents faces problems such as low efficiency, long cycle, and relatively low quality, which fails to meet current demands.展开更多
State Administration for Market Regulation and National Standardization Administration of China have approved the following 290 national standards and 4 national standards with amendment.
State Administration for Market Regulation and National Standardization Administration of China have approved the following 162 national standards and 20 national standards with amendment.
State Administration for Market Regulation and National Standardization Administration of China have approved the following 26 mandatory national standards and 1 mandatory national standard with amendment.
State Administration for Market Regulation and National Standardization Administration of China have approved the foreign language version of the following 73 national standards.
基金funded by the FWO(1S34321N)the Fondation Charcot Stichting(to TV and RS)。
文摘Historically,"big pharma"did most central nervous system drug discovery R&D in-house.Yet,in modern times their"management reductionism"resulted in disappointing pipelines and pharma resided to(late)development,regulatory approval,and marketing(Thong,2015).This had significant consequences for financing and executing research,resulting in a larger role for funding by governments and patient-organizations and a shift of research to academia(Mazzucato,2013).
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the following 278 voluntary national standards and 3 voluntary national standards with amendment.
文摘Objective To put forward some suggestions for improving the registration and regulation,the efficiency of evaluation,and approval of biosimilar in China so as to promote the development of biopharmaceutical industry and increase the accessibility of therapeutic drugs in China.Methods Literature related to the registration and regulation,evaluation and approval of biosimilars were sorted out to analyze the differences in China and the USA.Results and Conclusion Based on the analysis of the current situation of registration and regulation of biosimilars between China and the USA,it is suggested to improve the registration and regulation of biosimilars in China from the following four aspects:Establishing a biosimilar regulatory department,expanding the professional evaluation personnel,scientifically simplifying the registration and approval procedures,and constantly refining the types of communication meetings.
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the following 416 voluntary national standards and 3 voluntary national standards with amendment.
文摘To the Editor:Immune checkpoint inhibitors(ICIs)interact with critical factors involved in immunoregulation.Following the FDA approval of nivolumab as a second line therapy for unresectable hepatocellular carcinoma(HCC)in 2017,numerous HCC patients have experienced benefits from ICIs[1].In 2020,the FDA approved the combination of atezolizumab and bevacizumab as first line treatment for unresectable HCCs that have not undergone prior systemic treatments[2].ICIs are driving a transformative change in the field of cancer therapy.
文摘Ethical approval is the first essential step for medical master’s students to officially initiate research.This article discusses the ethical issues encountered in various types of research projects conducted by professional master’s students,the preparation of ethical application materials,conflicts between the timing of ethical applications and the clinical training rotation schedules,and the continuity of ethical applications among students within the same cohort and across different cohorts.
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the following 12 national standards and 3 national standards with amendment.
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the following 10 national standards and 1 national standard with amendment.
文摘Ministry:Rare earth export applications approved China has been approving all compliant rare earth export applications for civilian use without delay,the Ministry of Commerce said on Dec.4,2025.This comes after a survey claimed that several European businesses were already,or expecting to be,affected by China's export controls.
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the foreign language versions of the following 79 national standards.
文摘The digital economy has become an important impetus of global economic growth. The rapid development of emerging and key technological fields, such as the new generation of information technology and biotechnology, has put forward new requirements for standards development.However, the traditional mode of standards development relying on paper documents faces problems such as low efficiency, long cycle, and relatively low quality, which fails to meet current demands.
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the following 290 national standards and 4 national standards with amendment.
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the following 162 national standards and 20 national standards with amendment.
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the following 26 mandatory national standards and 1 mandatory national standard with amendment.
文摘State Administration for Market Regulation and National Standardization Administration of China have approved the foreign language version of the following 73 national standards.
