Since the first description of the concept of natural orifice translumenal endoscopic surgery (NOTES), a substantial number of clinical NOTES reports have appeared in the literature. This editorial reviews the availab...Since the first description of the concept of natural orifice translumenal endoscopic surgery (NOTES), a substantial number of clinical NOTES reports have appeared in the literature. This editorial reviews the available human data addressing research questions originally proposed by the white paper, including determining the optimal method of access for NOTES, developing safe methods of lumenal closure, suturing and anastomotic devices, advanced multitasking platforms, addressing the risk of infection, managing complications, addressing challenges with visualization, and training for NOTES procedures. An analysis of the literature reveals that so far transvaginal access and closure appear to be the most feasible techniques for NOTES, with a limited, but growing transgastric, transrectal, and transesophageal NOTES experience in humans. The theoretically increased risk of infection as a result of NOTES procedures has not been substantiated in transvaginal and transgastric procedures so far. Development of suturing and anastomotic devices and advanced platforms for NOTES has progressed slowly, with limited clinical data on their use so far. Data onthe optimal management and incidence of intraoperative complications remain sparse, although possible factors contributing to complications are discussed. Finally, this editorial discusses the likely direction of future NOTES development and its possible role in clinical practice.展开更多
The article studies China＇s development assistance policy during the last decades. It shows the evolution of Chinese approach to providing foreign aid. The analysis is based on White Papers on China＇s Foreign Aid fr...The article studies China＇s development assistance policy during the last decades. It shows the evolution of Chinese approach to providing foreign aid. The analysis is based on White Papers on China＇s Foreign Aid from 2011 and 2014, theoretical studies, and reports on China＇s foreign aid. From the beginning of the 21st century, China has become one of the most important emerging donors. Chinese aid is primarily provided to Africa, Latin America, Asia, and the Pacific. Depending on the region, the assistance is directed to large-scale infrastructure projects, energy facilities, or natural resource development activities. The aid is combined with investments and trade arrangements. Generally, China＇s aid programme is driven by economic, diplomatic, and strategic objectives. The rules according to which Chinese assistance is provided to developing countries differ significantly from the rules established by Development Assistance Committee （DAC） members. Aid-receiving countries do not have to fulfil strict development assistance regimes and adopt specific economic policies and targets.展开更多
New Wide Group（NW Group）officially released its second CSR White Paper in Shanghai on October 12th,written in both Chinese and English and meeting both GRI G4 and CSR-GATEs standard in textile industry.The Report fu...New Wide Group（NW Group）officially released its second CSR White Paper in Shanghai on October 12th,written in both Chinese and English and meeting both GRI G4 and CSR-GATEs standard in textile industry.The Report fully discloses the performance that NW Group has achieved in CRS managerial principles,key issues,response and action,and showcases the results of its long-termcommitment to social responsibility.展开更多
The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significane...The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.展开更多
The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not...The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name product.In China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs.In the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic drugs.At the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code directory.It can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.展开更多
The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential...The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.展开更多
文摘Since the first description of the concept of natural orifice translumenal endoscopic surgery (NOTES), a substantial number of clinical NOTES reports have appeared in the literature. This editorial reviews the available human data addressing research questions originally proposed by the white paper, including determining the optimal method of access for NOTES, developing safe methods of lumenal closure, suturing and anastomotic devices, advanced multitasking platforms, addressing the risk of infection, managing complications, addressing challenges with visualization, and training for NOTES procedures. An analysis of the literature reveals that so far transvaginal access and closure appear to be the most feasible techniques for NOTES, with a limited, but growing transgastric, transrectal, and transesophageal NOTES experience in humans. The theoretically increased risk of infection as a result of NOTES procedures has not been substantiated in transvaginal and transgastric procedures so far. Development of suturing and anastomotic devices and advanced platforms for NOTES has progressed slowly, with limited clinical data on their use so far. Data onthe optimal management and incidence of intraoperative complications remain sparse, although possible factors contributing to complications are discussed. Finally, this editorial discusses the likely direction of future NOTES development and its possible role in clinical practice.
文摘The article studies China＇s development assistance policy during the last decades. It shows the evolution of Chinese approach to providing foreign aid. The analysis is based on White Papers on China＇s Foreign Aid from 2011 and 2014, theoretical studies, and reports on China＇s foreign aid. From the beginning of the 21st century, China has become one of the most important emerging donors. Chinese aid is primarily provided to Africa, Latin America, Asia, and the Pacific. Depending on the region, the assistance is directed to large-scale infrastructure projects, energy facilities, or natural resource development activities. The aid is combined with investments and trade arrangements. Generally, China＇s aid programme is driven by economic, diplomatic, and strategic objectives. The rules according to which Chinese assistance is provided to developing countries differ significantly from the rules established by Development Assistance Committee （DAC） members. Aid-receiving countries do not have to fulfil strict development assistance regimes and adopt specific economic policies and targets.
文摘New Wide Group（NW Group）officially released its second CSR White Paper in Shanghai on October 12th,written in both Chinese and English and meeting both GRI G4 and CSR-GATEs standard in textile industry.The Report fully discloses the performance that NW Group has achieved in CRS managerial principles,key issues,response and action,and showcases the results of its long-termcommitment to social responsibility.
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.
基金National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’(Grant No.2017ZX09101001,Beijing,China)
文摘The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name product.In China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic drugs.In the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic drugs.At the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code directory.It can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.
基金Carry out quality evaluation research of generic medicinal product control based on domestic product,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing,China。
文摘The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.
