This paper explored stakeholders’ compliance with existing laws and regulations related to construction health and safety (CHS) in the Ghanaian construction industry (GCI). Qualitative research approach was adopted f...This paper explored stakeholders’ compliance with existing laws and regulations related to construction health and safety (CHS) in the Ghanaian construction industry (GCI). Qualitative research approach was adopted for the data collection, using semi-structured interview guide. An in-depth face-to-face interview based on the grounded theory approach was conducted with actors who play important roles in ensuring health and safety at the construction site as well as key officers and professionals who are the major stakeholders in the GCI. Content analysis was adopted for the analysis of the qualitative data. The findings of the study show customary laws, bye laws, Labour Act, 2003 (Act 651), Local Governance Act, 2016 (Act 936) and the contract document as the key existing CHS related laws and regulations that the stakeholders comply with. The stakeholders also identified the following construction health and safety related regulations in the GCI which have low compliance rate: Factories, Shops and Offices Act, 1974 (Act 323), Environmental Protection Act, 1994 (Act 490), among others. The findings of the research contribute to knowledge of stakeholders’ compliance with existing laws and regulations related to CHS, and underscore the need to ensure monitoring and enforce compliance in the GCI. The findings further identify areas for stakeholders to focus attention on ensuring good health and safety practices, and also expose critical training and education needs for stakeholders in the GCI. The findings provide valuable insights on stakeholders’ compliance with laws and regulations related to CHS in Ghana, which may be applicable to other developing countries with similar construction industry.展开更多
The lack of descriptions regarding the order of precedence between the local laws of cities with subordinate districts and the regulations of provincial governments in Legislation Law of the People's Republic of C...The lack of descriptions regarding the order of precedence between the local laws of cities with subordinate districts and the regulations of provincial governments in Legislation Law of the People's Republic of China(Legislation Law) has led to two divergent views. One holds that "the local laws of cities with subordinate districts should take precedence over the regulations of provincial governments," while the other supports the exact opposite. This is a value judgment issue in legislation. To reach a solution, we need to clarify the premises based on the characteristics of the laws in question so that a basic common ground can be established for discussion. The first premise for traditional legislation is that a law should be based on experience as well as logic; the second is that the experience of authority subjects, plus the three aspects of logic should outweigh the experience of social subjects, plus the three aspects of logic. With respect to postmodern legislation, the first premise is that experience should override logic, and the second is that the experience of the authority subject should take precedence over that of social subject, with no requirements for logical consistency. Since Legislation Law fal s into the category of postmodern legislation, according to the premises, the argument that the local laws of cities with subordinate districts should take precedence enjoys wider acceptance, but the view is logically challenged in terms of conceptual consistency, system consistency and principle consistency. More studies must be conducted to facilitate the discussion.展开更多
Although traditional Chinese medicine(TCM)has been a part of the Malaya and the Malaysia people’s method of maintaining health and well-being for many centuries,it was never been enrolled in the public health-care sy...Although traditional Chinese medicine(TCM)has been a part of the Malaya and the Malaysia people’s method of maintaining health and well-being for many centuries,it was never been enrolled in the public health-care system.However,the rising cost of Western drugs and the increasing number of people frequenting TCM has driven the government to search for cheaper options and to look into its safe practice.In 1992,the government mandated all TCM herbal products to be registered with the National Pharmaceutical Control Bureau.All TCM products sold in Malaysia are now Good Manufacturing Practice certified.The government has also established a Traditional and Complementary Medicine Division within the Ministry of Health.Between 2008 and 2014,a traditional and complementary medicine unit was set up in major hospitals in all states.TCM is one of the main services offered by the unit.In 2016,the government enacted the Traditional and Complementary Medicine Act to regulate the TCM practice.Subsequently,a 10-vear blueprint has been drawn to support the development of all traditional and complementary medicines in Malaysia.This article aims to provide a brief overview on the regulatory development of TCM in Malaysia.展开更多
1.Introduction On January 1,2008,the Labor Contract Law of the People's Republic of China(LCL)became effective,resulting in wide- spread changes in labor policy for all companies and other af- fected organizations...1.Introduction On January 1,2008,the Labor Contract Law of the People's Republic of China(LCL)became effective,resulting in wide- spread changes in labor policy for all companies and other af- fected organizations.As is the case with legislating in China, many details were left for resolution in implementing regulations,展开更多
Legal management is the fundamental guarantee of urban rail transit management's benign operation; and the comprehensive legal management of urban rail transit is also the important development trend of urban rail tr...Legal management is the fundamental guarantee of urban rail transit management's benign operation; and the comprehensive legal management of urban rail transit is also the important development trend of urban rail transit in the world. This article aims to analyze the problems existing in China's urban rail transit legal management, to improve the corresponding laws and regulations system, and to put forward some suggestions on how to optimize the urban rail transit legal management.展开更多
Objective To analyze laws, regulations and the responsibilities of relevant authorities for vaccine quality control and to provide suggestions for improving vaccine quality control system in China. Methods Laws and ru...Objective To analyze laws, regulations and the responsibilities of relevant authorities for vaccine quality control and to provide suggestions for improving vaccine quality control system in China. Methods Laws and rules issued by related authorities were classified and studied. Results and Conclusion There are still some problems in the basic laws and regulations, including the lack of legal basis, the unclear responsibilities of relevant authorities and so on. We should improve the current laws, regulations as well as the responsibilities of the authorities so as to build up a sound system of vaccine traceability gradually.展开更多
The issue of education for people with disabilities has become of increasing concern. How can we effectively guarantee the basic right to education for persons with disabilities? Will the revised Regulation on Educati...The issue of education for people with disabilities has become of increasing concern. How can we effectively guarantee the basic right to education for persons with disabilities? Will the revised Regulation on Education for Persons with Disabilities meet their needs? This article takes the Regulation on Education for Persons with Disabilities as the core and compares it with the related special educational laws of the United States, Britain and Japan. The following conclusions were drawn from this study: In terms of educational concept, the three countries follow the concept of inclusive education, and pursue equity and educational justice. They not only pay attention to inclusive education but also focus on improving the quality of education for students with disabilities. All three countries focus on accommodating children with special needs, but each implements its programs in a different way. These practices can be used as reference for the development of a special needs education law in China.展开更多
The determining factor of<em> Setaria italica </em>(L.) P. Beauv. is the coupling of its flowering stage and outcrossing rate which leads to low and unstable seed yields in self-pollinated foxtail millet h...The determining factor of<em> Setaria italica </em>(L.) P. Beauv. is the coupling of its flowering stage and outcrossing rate which leads to low and unstable seed yields in self-pollinated foxtail millet hybrids and thereby limits their large-scale application. In this study, Datong 27, Datong 29 and gu 83 were screened and identified through meticulous observations of their pollination habitats. High exposure rate, degree of exposure and plump of stigma are good factors to accept foreign pollen. Datong 27 and Datong 29 have some additional characteristics, such as long filaments and exposed and full anthers that contain a large amount of pollen. We transformed into a series of stigma-exposed and plump sterile lines that easily accepted exotic pollen. New restorer lines with anthers that were full of powder and exhibited quick recovery, which improved the parental lines’ heterosexual characteristics. By tracking and monitoring the leaf development of the new sterile and restorer lines, a coupling law of leaf development was determined and a series of flowering control measures were formulated. These factors ensured that the parental lines encounter one another during the flowering stage. By utilizing fertilizer and water, the vitality of the female stigma, amount of powder scattered and powder loosening time were prolonged, which increased hybrid seed yields from 1500 to 3000 kg/hm<sup>2</sup>. These findings were helpful in resolving the technical problems of seed production that restricted the propagation of foxtail millet hybrids and supporting future large-scale applications.展开更多
In recent years, rural tourism in China vigorously developed, which promoted economic and social development in rural area. However, serious environmental problems appeared in the development process of rural tourism ...In recent years, rural tourism in China vigorously developed, which promoted economic and social development in rural area. However, serious environmental problems appeared in the development process of rural tourism since rural tourism lacked effective and comprehensive super- vision. These environmental problems included environmental pollution and ecological damage. However, environmental legal system about rural tourism had many problems, such as the lagged legislation, the absence of law enforcement supervision, imperfect judicial system and weak law- abiding awareness. Therefore, it became the solution to solve environmental problems brought by rural tourism in China, and was also the safe- guard for promoting sustainable development of rural tourism in China to establish a sound legal system for rural tourism, implement strict law en- forcement supervision of rural tourism, build litigation system of environmental public interest and enhance law-abiding awareness of rural tourism. For legal defects of regulating rural tourism and its induced environmental problems in China, we tried to perfect regulation of environmental law for rural tourism in China.展开更多
In the performance experiment of organic Rankine cycle power generation experimental system, the loadresistance-regulation method is one of the most important regulation methods. However, the regulation law has not be...In the performance experiment of organic Rankine cycle power generation experimental system, the loadresistance-regulation method is one of the most important regulation methods. However, the regulation law has not been clear enough to guide the experiment, which is unfavorable to the experimental research on organic Rankine cycle. In this paper the regulation law of turbine and generator by the load-resistance-regulation method is studied theoretically and experimentally. The results show that when the thermal cycle parameters keep constant, the turbine speed increases with the increase of load resistance and there is a maximum value of transmission-generator efficiency with the variation of the turbine speed; when the turbine speed and generator speed keep constant, the transmissiongenerator efficiency decreases and gradually tends to zero with the increase of load resistance.展开更多
Laws and policies impose many information handling requirements on business practices. Compliance with such regu-lations requires identification of conflicting interpretations of regulatory conditions. Current softwar...Laws and policies impose many information handling requirements on business practices. Compliance with such regu-lations requires identification of conflicting interpretations of regulatory conditions. Current software engineering methods extract software requirements by converting legal text into semiformal constraints and rules. In this paper we complement these methods with a state-based model that includes all possibilities of information flow. We show that such a model provides a foundation for the interpretation process.展开更多
The aim of this study was to analyze the contents of Reg.(EU)No.429/2016,and to assess its role in guaranteeing the efficient application of the disease prevention and control rules into member state.Furthermore,the a...The aim of this study was to analyze the contents of Reg.(EU)No.429/2016,and to assess its role in guaranteeing the efficient application of the disease prevention and control rules into member state.Furthermore,the authors evaluated the impact of the abovementioned Regulation on the legislation on public health and food safety already in force in Europe(Regulations EC No.178/2002,No.882/2004,No.853/2004)and considered the global impact of the new rules on the effective functioning of the internal market.The study pays attention also to the TFEU(treaty of lisbon on the functioning of the European union)procedure to delegate to the commission the power to adopt non-legislative acts of general application that supplement or amend certain non-essential elements of a legislative act.展开更多
The paper analyzes the external economy of pollution, Two different cost models of enterprises are established From the point of enterprises and the government, the measures of eliminating the externalily are discusse...The paper analyzes the external economy of pollution, Two different cost models of enterprises are established From the point of enterprises and the government, the measures of eliminating the externalily are discussed, and the limits the measures are analyzed.展开更多
Background and Aims: On November 24, 2009, Huu S. TIEU and Golden Sunrise Pharmaceutical, Inc. (Golden Sunrise) applied for the Technology and Innovation to be reviewed and evaluated by the U.S. Food and Drug Administ...Background and Aims: On November 24, 2009, Huu S. TIEU and Golden Sunrise Pharmaceutical, Inc. (Golden Sunrise) applied for the Technology and Innovation to be reviewed and evaluated by the U.S. Food and Drug Administration (FDA). In the review and evaluation, it was requested by Golden Sunrise designated the new indications for this application under Serious or Life-threatening conditions or diseases. Discussions followed with the FDA, Huu S. TIEU, and Golden Sunrise for FDA approval on new products and new indications on existing new Medical Technology and Innovation. It was agreed in Year-2015 that the FDA would take the request for new indications to the United States Congress to establish into FDA regulation and law. At that time the following was the FDA Guidance—“Emergency Use of a Test Article” is exempt from prior Institutional Review Board or Advisory Committee evaluation and approval, provided that such emergency use is reported to the Institutional Review Board within five working days after use. Expedited Institutional Review Board or Advisory Committee approval is not permitted in emergency use. There has been no funding to the authors for the writing or publication of this article. Methods: It was requested by Huu S. TIEU and Golden Sunrise in documents given to the FDA to have Serious or Life-threatening conditions or diseases indication be recognized by law. On August 08, 2015, the FDA responding to this request took the documentation produced by Golden Sunrise to the United States Congress on behalf of Golden Sunrise and Huu S. TIEU. This article encompasses the FDA regulatory method as well as the discussion and results of the establishment of the FDA and the 21<sup>st</sup> Century Cures Act. Results: On December 13, 2016, H.R.34—114<sup>th</sup> United States Congress (2015-2016) 21<sup>st</sup> Century CURES Act was signed into law by President Barack H. Obama which included the Serious or Life-threatening indication to be written into the CURES Act. In summary, the 21<sup>st</sup> Century Cures Act is a landmark piece of legislation that enjoyed broad bipartisan support in United States Congress. The main goals of the Act are impactful and should transform future cancer, neurologic, and precision medicine or drug research as well as aid individuals with mental health is intended to facilitate the prompt approval of new agents and devices, clinicians should be aware of the types of data behind an approval and take this into consideration when developing illnesses and opioid dependence. However, some of the wording within the CURES Act regarding the drug and device approval process may bring pause to health care providers including pharmacists. Although this wording and implementing care plans and counseling patients. The 21<sup>st</sup> Century Cures Act was incorporated into laws and regulations by the FDA under § 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products.展开更多
China's State Council,the country's Cabinet,issued an implementation regulation for Labor Contract Law on September 18 in an effort to clarify confusion surrounding the law.
It reviewed the backgrounds, contents and other aspects of several important cosmetic regulations issued recently, including the Filing of Non-special use Cosmetics in China, Integration of Whitening Cosmetics into Sp...It reviewed the backgrounds, contents and other aspects of several important cosmetic regulations issued recently, including the Filing of Non-special use Cosmetics in China, Integration of Whitening Cosmetics into Specialuse Cosmetics Administration, Inventory of Existing Cosmetic Ingredient in China, Safety and Technical Standards for Cosmetics, Guidance for Safety Risk Assessment of Cosmetics, and Cosmetic Production License Administration, to provide technical support for healthy and ordedy development of the cosmetic industry.展开更多
The supervision and administration of cosmetics and its two supporting documents related to efficacy,cosmetics classification rules and classification catalogue and evaluation standard of cosmetic efficacy claims,have...The supervision and administration of cosmetics and its two supporting documents related to efficacy,cosmetics classification rules and classification catalogue and evaluation standard of cosmetic efficacy claims,have been successively introduced and implemented,making China’s cosmetics industry officially enter the era of efficacy evaluation.In the time window when the new era is coming,the definitions of cosmetics in China and other countries are compared.The latest status and progress of regulations on cosmetic efficacy claims in China and other countries are summarized,and the standard methods or guidance of cosmetic efficacy evaluation at home and abroad are introduced.The enlightenment from the supervision systems of cosmetic efficacy in other cosmetic consumer markets around the world are discussed.In addition,the opportunities and challenges for cosmetic enterprises under the background of cosmetic law reform in China are also prospected.展开更多
文摘This paper explored stakeholders’ compliance with existing laws and regulations related to construction health and safety (CHS) in the Ghanaian construction industry (GCI). Qualitative research approach was adopted for the data collection, using semi-structured interview guide. An in-depth face-to-face interview based on the grounded theory approach was conducted with actors who play important roles in ensuring health and safety at the construction site as well as key officers and professionals who are the major stakeholders in the GCI. Content analysis was adopted for the analysis of the qualitative data. The findings of the study show customary laws, bye laws, Labour Act, 2003 (Act 651), Local Governance Act, 2016 (Act 936) and the contract document as the key existing CHS related laws and regulations that the stakeholders comply with. The stakeholders also identified the following construction health and safety related regulations in the GCI which have low compliance rate: Factories, Shops and Offices Act, 1974 (Act 323), Environmental Protection Act, 1994 (Act 490), among others. The findings of the research contribute to knowledge of stakeholders’ compliance with existing laws and regulations related to CHS, and underscore the need to ensure monitoring and enforce compliance in the GCI. The findings further identify areas for stakeholders to focus attention on ensuring good health and safety practices, and also expose critical training and education needs for stakeholders in the GCI. The findings provide valuable insights on stakeholders’ compliance with laws and regulations related to CHS in Ghana, which may be applicable to other developing countries with similar construction industry.
基金part of the results(presented in stages)of"Research on the Legislative System of Cities with Subordinate Districts"(16XFX004)-a program of National Social Sciences Fund in Western China"Empirical Research on Local Legislation"(16XW16)-a research focus of Sichuan Academy of Social Sciences under a key program launched by the Publicity Department of the CPC Sichuan Provincial Committee
文摘The lack of descriptions regarding the order of precedence between the local laws of cities with subordinate districts and the regulations of provincial governments in Legislation Law of the People's Republic of China(Legislation Law) has led to two divergent views. One holds that "the local laws of cities with subordinate districts should take precedence over the regulations of provincial governments," while the other supports the exact opposite. This is a value judgment issue in legislation. To reach a solution, we need to clarify the premises based on the characteristics of the laws in question so that a basic common ground can be established for discussion. The first premise for traditional legislation is that a law should be based on experience as well as logic; the second is that the experience of authority subjects, plus the three aspects of logic should outweigh the experience of social subjects, plus the three aspects of logic. With respect to postmodern legislation, the first premise is that experience should override logic, and the second is that the experience of the authority subject should take precedence over that of social subject, with no requirements for logical consistency. Since Legislation Law fal s into the category of postmodern legislation, according to the premises, the argument that the local laws of cities with subordinate districts should take precedence enjoys wider acceptance, but the view is logically challenged in terms of conceptual consistency, system consistency and principle consistency. More studies must be conducted to facilitate the discussion.
文摘Although traditional Chinese medicine(TCM)has been a part of the Malaya and the Malaysia people’s method of maintaining health and well-being for many centuries,it was never been enrolled in the public health-care system.However,the rising cost of Western drugs and the increasing number of people frequenting TCM has driven the government to search for cheaper options and to look into its safe practice.In 1992,the government mandated all TCM herbal products to be registered with the National Pharmaceutical Control Bureau.All TCM products sold in Malaysia are now Good Manufacturing Practice certified.The government has also established a Traditional and Complementary Medicine Division within the Ministry of Health.Between 2008 and 2014,a traditional and complementary medicine unit was set up in major hospitals in all states.TCM is one of the main services offered by the unit.In 2016,the government enacted the Traditional and Complementary Medicine Act to regulate the TCM practice.Subsequently,a 10-vear blueprint has been drawn to support the development of all traditional and complementary medicines in Malaysia.This article aims to provide a brief overview on the regulatory development of TCM in Malaysia.
文摘1.Introduction On January 1,2008,the Labor Contract Law of the People's Republic of China(LCL)became effective,resulting in wide- spread changes in labor policy for all companies and other af- fected organizations.As is the case with legislating in China, many details were left for resolution in implementing regulations,
文摘Legal management is the fundamental guarantee of urban rail transit management's benign operation; and the comprehensive legal management of urban rail transit is also the important development trend of urban rail transit in the world. This article aims to analyze the problems existing in China's urban rail transit legal management, to improve the corresponding laws and regulations system, and to put forward some suggestions on how to optimize the urban rail transit legal management.
文摘Objective To analyze laws, regulations and the responsibilities of relevant authorities for vaccine quality control and to provide suggestions for improving vaccine quality control system in China. Methods Laws and rules issued by related authorities were classified and studied. Results and Conclusion There are still some problems in the basic laws and regulations, including the lack of legal basis, the unclear responsibilities of relevant authorities and so on. We should improve the current laws, regulations as well as the responsibilities of the authorities so as to build up a sound system of vaccine traceability gradually.
文摘The issue of education for people with disabilities has become of increasing concern. How can we effectively guarantee the basic right to education for persons with disabilities? Will the revised Regulation on Education for Persons with Disabilities meet their needs? This article takes the Regulation on Education for Persons with Disabilities as the core and compares it with the related special educational laws of the United States, Britain and Japan. The following conclusions were drawn from this study: In terms of educational concept, the three countries follow the concept of inclusive education, and pursue equity and educational justice. They not only pay attention to inclusive education but also focus on improving the quality of education for students with disabilities. All three countries focus on accommodating children with special needs, but each implements its programs in a different way. These practices can be used as reference for the development of a special needs education law in China.
文摘The determining factor of<em> Setaria italica </em>(L.) P. Beauv. is the coupling of its flowering stage and outcrossing rate which leads to low and unstable seed yields in self-pollinated foxtail millet hybrids and thereby limits their large-scale application. In this study, Datong 27, Datong 29 and gu 83 were screened and identified through meticulous observations of their pollination habitats. High exposure rate, degree of exposure and plump of stigma are good factors to accept foreign pollen. Datong 27 and Datong 29 have some additional characteristics, such as long filaments and exposed and full anthers that contain a large amount of pollen. We transformed into a series of stigma-exposed and plump sterile lines that easily accepted exotic pollen. New restorer lines with anthers that were full of powder and exhibited quick recovery, which improved the parental lines’ heterosexual characteristics. By tracking and monitoring the leaf development of the new sterile and restorer lines, a coupling law of leaf development was determined and a series of flowering control measures were formulated. These factors ensured that the parental lines encounter one another during the flowering stage. By utilizing fertilizer and water, the vitality of the female stigma, amount of powder scattered and powder loosening time were prolonged, which increased hybrid seed yields from 1500 to 3000 kg/hm<sup>2</sup>. These findings were helpful in resolving the technical problems of seed production that restricted the propagation of foxtail millet hybrids and supporting future large-scale applications.
文摘In recent years, rural tourism in China vigorously developed, which promoted economic and social development in rural area. However, serious environmental problems appeared in the development process of rural tourism since rural tourism lacked effective and comprehensive super- vision. These environmental problems included environmental pollution and ecological damage. However, environmental legal system about rural tourism had many problems, such as the lagged legislation, the absence of law enforcement supervision, imperfect judicial system and weak law- abiding awareness. Therefore, it became the solution to solve environmental problems brought by rural tourism in China, and was also the safe- guard for promoting sustainable development of rural tourism in China to establish a sound legal system for rural tourism, implement strict law en- forcement supervision of rural tourism, build litigation system of environmental public interest and enhance law-abiding awareness of rural tourism. For legal defects of regulating rural tourism and its induced environmental problems in China, we tried to perfect regulation of environmental law for rural tourism in China.
基金Supported by the National Natural Science Foundation of China(No.51306198)the Specialized Research Fund for the Doctoral Program of Higher Education of China(No.20110032110046)
文摘In the performance experiment of organic Rankine cycle power generation experimental system, the loadresistance-regulation method is one of the most important regulation methods. However, the regulation law has not been clear enough to guide the experiment, which is unfavorable to the experimental research on organic Rankine cycle. In this paper the regulation law of turbine and generator by the load-resistance-regulation method is studied theoretically and experimentally. The results show that when the thermal cycle parameters keep constant, the turbine speed increases with the increase of load resistance and there is a maximum value of transmission-generator efficiency with the variation of the turbine speed; when the turbine speed and generator speed keep constant, the transmissiongenerator efficiency decreases and gradually tends to zero with the increase of load resistance.
文摘Laws and policies impose many information handling requirements on business practices. Compliance with such regu-lations requires identification of conflicting interpretations of regulatory conditions. Current software engineering methods extract software requirements by converting legal text into semiformal constraints and rules. In this paper we complement these methods with a state-based model that includes all possibilities of information flow. We show that such a model provides a foundation for the interpretation process.
文摘The aim of this study was to analyze the contents of Reg.(EU)No.429/2016,and to assess its role in guaranteeing the efficient application of the disease prevention and control rules into member state.Furthermore,the authors evaluated the impact of the abovementioned Regulation on the legislation on public health and food safety already in force in Europe(Regulations EC No.178/2002,No.882/2004,No.853/2004)and considered the global impact of the new rules on the effective functioning of the internal market.The study pays attention also to the TFEU(treaty of lisbon on the functioning of the European union)procedure to delegate to the commission the power to adopt non-legislative acts of general application that supplement or amend certain non-essential elements of a legislative act.
文摘The paper analyzes the external economy of pollution, Two different cost models of enterprises are established From the point of enterprises and the government, the measures of eliminating the externalily are discussed, and the limits the measures are analyzed.
文摘Background and Aims: On November 24, 2009, Huu S. TIEU and Golden Sunrise Pharmaceutical, Inc. (Golden Sunrise) applied for the Technology and Innovation to be reviewed and evaluated by the U.S. Food and Drug Administration (FDA). In the review and evaluation, it was requested by Golden Sunrise designated the new indications for this application under Serious or Life-threatening conditions or diseases. Discussions followed with the FDA, Huu S. TIEU, and Golden Sunrise for FDA approval on new products and new indications on existing new Medical Technology and Innovation. It was agreed in Year-2015 that the FDA would take the request for new indications to the United States Congress to establish into FDA regulation and law. At that time the following was the FDA Guidance—“Emergency Use of a Test Article” is exempt from prior Institutional Review Board or Advisory Committee evaluation and approval, provided that such emergency use is reported to the Institutional Review Board within five working days after use. Expedited Institutional Review Board or Advisory Committee approval is not permitted in emergency use. There has been no funding to the authors for the writing or publication of this article. Methods: It was requested by Huu S. TIEU and Golden Sunrise in documents given to the FDA to have Serious or Life-threatening conditions or diseases indication be recognized by law. On August 08, 2015, the FDA responding to this request took the documentation produced by Golden Sunrise to the United States Congress on behalf of Golden Sunrise and Huu S. TIEU. This article encompasses the FDA regulatory method as well as the discussion and results of the establishment of the FDA and the 21<sup>st</sup> Century Cures Act. Results: On December 13, 2016, H.R.34—114<sup>th</sup> United States Congress (2015-2016) 21<sup>st</sup> Century CURES Act was signed into law by President Barack H. Obama which included the Serious or Life-threatening indication to be written into the CURES Act. In summary, the 21<sup>st</sup> Century Cures Act is a landmark piece of legislation that enjoyed broad bipartisan support in United States Congress. The main goals of the Act are impactful and should transform future cancer, neurologic, and precision medicine or drug research as well as aid individuals with mental health is intended to facilitate the prompt approval of new agents and devices, clinicians should be aware of the types of data behind an approval and take this into consideration when developing illnesses and opioid dependence. However, some of the wording within the CURES Act regarding the drug and device approval process may bring pause to health care providers including pharmacists. Although this wording and implementing care plans and counseling patients. The 21<sup>st</sup> Century Cures Act was incorporated into laws and regulations by the FDA under § 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products.
文摘China's State Council,the country's Cabinet,issued an implementation regulation for Labor Contract Law on September 18 in an effort to clarify confusion surrounding the law.
文摘It reviewed the backgrounds, contents and other aspects of several important cosmetic regulations issued recently, including the Filing of Non-special use Cosmetics in China, Integration of Whitening Cosmetics into Specialuse Cosmetics Administration, Inventory of Existing Cosmetic Ingredient in China, Safety and Technical Standards for Cosmetics, Guidance for Safety Risk Assessment of Cosmetics, and Cosmetic Production License Administration, to provide technical support for healthy and ordedy development of the cosmetic industry.
文摘The supervision and administration of cosmetics and its two supporting documents related to efficacy,cosmetics classification rules and classification catalogue and evaluation standard of cosmetic efficacy claims,have been successively introduced and implemented,making China’s cosmetics industry officially enter the era of efficacy evaluation.In the time window when the new era is coming,the definitions of cosmetics in China and other countries are compared.The latest status and progress of regulations on cosmetic efficacy claims in China and other countries are summarized,and the standard methods or guidance of cosmetic efficacy evaluation at home and abroad are introduced.The enlightenment from the supervision systems of cosmetic efficacy in other cosmetic consumer markets around the world are discussed.In addition,the opportunities and challenges for cosmetic enterprises under the background of cosmetic law reform in China are also prospected.