On May 28, 2019 Chinese Cosmetics Development Conference was held in Beijing. At the conference, Li Nan, chief of the General Division, Supervision Department of the State Food and Drug Administration introduced China...On May 28, 2019 Chinese Cosmetics Development Conference was held in Beijing. At the conference, Li Nan, chief of the General Division, Supervision Department of the State Food and Drug Administration introduced China’s development concerning the cosmetics supervisory rules and regulations from the perspectives of legislation plan and thinking. He mentioned that the regulations on supervision and administration of cosmetics are expected to be released this year, and the regulations on cosmetic registration and label management.展开更多
Following is an interview given by Shao Mingli, director-general of China＇s State Food and Drug Administration to our reporter on what is being done to ensure food and drug safety in China. As everybody knows, food a...Following is an interview given by Shao Mingli, director-general of China＇s State Food and Drug Administration to our reporter on what is being done to ensure food and drug safety in China. As everybody knows, food and drug safety is vital to people＇s lives.展开更多
Background: Due to their delicious taste, high nutritional content, and health benefits, fruit juices are well-known drinks in many countries and are now an essential component of the modern diet. Objective: Determini...Background: Due to their delicious taste, high nutritional content, and health benefits, fruit juices are well-known drinks in many countries and are now an essential component of the modern diet. Objective: Determining the microbiological quality of both packaged and freshly made fruit and milk juices. Method: The spread-plate approach was employed to isolate and count the bacteria. 90 ml of sterile peptone water were blended with 10 ml of well-mixed, packed, and freshly made fruit juices. The samples were sequentially diluted (101 - 105) in accordance with the Indian Manual of Food Microbiological Testing Methods. Results: From eight samples of imported packaged fruit and milk juice, the average of total coliform, staphylococci, and viable bacterial counts were zero, 1.39 × 102, and 2 × 102 CFU/ml, respectively. In contrast, from three samples of locally produced fruit and milk juice, the average of total coliform, staphylococci, and viable bacterial counts were zero, 5.83 × 102, and 2.73 × 103 CFU/ml, respectively. Four samples of handmade prepared fruit and milk juices had a mean of total coliform, staphylococci, and viable bacterial count of 1.441 × 104, 4.1 × 103, and 2.35 × 105 CFU/ml, respectively. Conclusion: 33.3% of the results from microbiological analysis of freshly made fruit and milk juices met the permissible range of the Revised Microbiological Standards for Fruit and Vegetables and Their Products, which were published in 2018 and as well as the Hong Kong Center for Food Safety, whereas 66.7% of the microbiological analyses of freshly prepared fruit and milk juices were above the permissible reference range of GSO standard 2000. 12.5% of the investigated imported and packed fruits and milk juices had one failed test (TSC), which was above the acceptable limit, 87.5% of the tested samples of fruit and milk juices fulfilled the necessary standards of TCC, TVBC, and TSC. 100% of the tested locally manufactured fruit and milk juices complied with TSC, TCC, and TVBC requirements. All investigations showed that freshly made fruit and milk juices were heavily contaminated (Total viable bacterial count, total coliform count, and total staphylococcus count). .展开更多
为加快创新抗肿瘤药物和医疗器械的审批速度,美国食品药品管理局(Food and Drug Administration,FDA)为肿瘤相关产品的审评成立肿瘤卓越中心。本文通过对肿瘤卓越中心的成立背景、机构设置和工作机制等进行简介,从我国新药审评审批制度...为加快创新抗肿瘤药物和医疗器械的审批速度,美国食品药品管理局(Food and Drug Administration,FDA)为肿瘤相关产品的审评成立肿瘤卓越中心。本文通过对肿瘤卓越中心的成立背景、机构设置和工作机制等进行简介,从我国新药审评审批制度改革的角度提出启示与建议。展开更多
近年来,随着我国输美食品的不断增长,美国食品药品监督管理局(Food and Drug Administration,FDA)不断加强对我国输美食品生产企业的检查力度。2016年质检总局(General Administration of Quality Supervision,AQSIQ)对65家出口食品生...近年来,随着我国输美食品的不断增长,美国食品药品监督管理局(Food and Drug Administration,FDA)不断加强对我国输美食品生产企业的检查力度。2016年质检总局(General Administration of Quality Supervision,AQSIQ)对65家出口食品生产企业接受检查案例进行调研,发现随着2011年美国《食品安全现代法》(Food Safety Modernization Act,FSMA)的颁布,美国FDA的检查要求日趋严格,检查范围逐年扩大,对我国输美食品生产企业造成较大影响。本文通过分析美国FDA对我国输美食品生产企业的检查内容,总结该检查对企业造成的主要影响,并提出了相应的应对建议和措施,旨在提醒我国输美食品生产企业沉着应对,依据相关法律法规,制定好"人、机、料、法、环"各个环节的规章制度并严格实施,促使企业顺利通过美国FDA的现场检查,使得对美贸易更加顺畅。展开更多
真实世界研究(Real World Study,RWS)是在真实临床实践中评估干预措施安全性和有效性的一种临床研究。2018年12月,美国食品药品监督管理局(FDA)发布了《真实世界证据计划框架》,以指导未来用于新药审批决策的真实世界研究的开展。《真...真实世界研究(Real World Study,RWS)是在真实临床实践中评估干预措施安全性和有效性的一种临床研究。2018年12月,美国食品药品监督管理局(FDA)发布了《真实世界证据计划框架》,以指导未来用于新药审批决策的真实世界研究的开展。《真实世界证据计划框架》因其用途属性,对开展中药新药的真实世界研究有重要参考价值。作者通过对框架核心内容的解读,同时结合真实世界临床研究与中医药干预措施的共通点进行分析,可为进一步推动RWS应用于中药新药的研发提供参考。展开更多
文摘On May 28, 2019 Chinese Cosmetics Development Conference was held in Beijing. At the conference, Li Nan, chief of the General Division, Supervision Department of the State Food and Drug Administration introduced China’s development concerning the cosmetics supervisory rules and regulations from the perspectives of legislation plan and thinking. He mentioned that the regulations on supervision and administration of cosmetics are expected to be released this year, and the regulations on cosmetic registration and label management.
文摘Following is an interview given by Shao Mingli, director-general of China＇s State Food and Drug Administration to our reporter on what is being done to ensure food and drug safety in China. As everybody knows, food and drug safety is vital to people＇s lives.
文摘Background: Due to their delicious taste, high nutritional content, and health benefits, fruit juices are well-known drinks in many countries and are now an essential component of the modern diet. Objective: Determining the microbiological quality of both packaged and freshly made fruit and milk juices. Method: The spread-plate approach was employed to isolate and count the bacteria. 90 ml of sterile peptone water were blended with 10 ml of well-mixed, packed, and freshly made fruit juices. The samples were sequentially diluted (101 - 105) in accordance with the Indian Manual of Food Microbiological Testing Methods. Results: From eight samples of imported packaged fruit and milk juice, the average of total coliform, staphylococci, and viable bacterial counts were zero, 1.39 × 102, and 2 × 102 CFU/ml, respectively. In contrast, from three samples of locally produced fruit and milk juice, the average of total coliform, staphylococci, and viable bacterial counts were zero, 5.83 × 102, and 2.73 × 103 CFU/ml, respectively. Four samples of handmade prepared fruit and milk juices had a mean of total coliform, staphylococci, and viable bacterial count of 1.441 × 104, 4.1 × 103, and 2.35 × 105 CFU/ml, respectively. Conclusion: 33.3% of the results from microbiological analysis of freshly made fruit and milk juices met the permissible range of the Revised Microbiological Standards for Fruit and Vegetables and Their Products, which were published in 2018 and as well as the Hong Kong Center for Food Safety, whereas 66.7% of the microbiological analyses of freshly prepared fruit and milk juices were above the permissible reference range of GSO standard 2000. 12.5% of the investigated imported and packed fruits and milk juices had one failed test (TSC), which was above the acceptable limit, 87.5% of the tested samples of fruit and milk juices fulfilled the necessary standards of TCC, TVBC, and TSC. 100% of the tested locally manufactured fruit and milk juices complied with TSC, TCC, and TVBC requirements. All investigations showed that freshly made fruit and milk juices were heavily contaminated (Total viable bacterial count, total coliform count, and total staphylococcus count). .
文摘近年来,随着我国输美食品的不断增长,美国食品药品监督管理局(Food and Drug Administration,FDA)不断加强对我国输美食品生产企业的检查力度。2016年质检总局(General Administration of Quality Supervision,AQSIQ)对65家出口食品生产企业接受检查案例进行调研,发现随着2011年美国《食品安全现代法》(Food Safety Modernization Act,FSMA)的颁布,美国FDA的检查要求日趋严格,检查范围逐年扩大,对我国输美食品生产企业造成较大影响。本文通过分析美国FDA对我国输美食品生产企业的检查内容,总结该检查对企业造成的主要影响,并提出了相应的应对建议和措施,旨在提醒我国输美食品生产企业沉着应对,依据相关法律法规,制定好"人、机、料、法、环"各个环节的规章制度并严格实施,促使企业顺利通过美国FDA的现场检查,使得对美贸易更加顺畅。
文摘真实世界研究(Real World Study,RWS)是在真实临床实践中评估干预措施安全性和有效性的一种临床研究。2018年12月,美国食品药品监督管理局(FDA)发布了《真实世界证据计划框架》,以指导未来用于新药审批决策的真实世界研究的开展。《真实世界证据计划框架》因其用途属性,对开展中药新药的真实世界研究有重要参考价值。作者通过对框架核心内容的解读,同时结合真实世界临床研究与中医药干预措施的共通点进行分析,可为进一步推动RWS应用于中药新药的研发提供参考。
