Based on this evidence and many other examples, this paper advocates a drastic overhaul of the system, in which a distinction is made between simple, standard projects, less simple solutions that can be assessed with ...Based on this evidence and many other examples, this paper advocates a drastic overhaul of the system, in which a distinction is made between simple, standard projects, less simple solutions that can be assessed with performance requirements, and high-value projects which are handled in accordance with the science of probabilistics. Next to or in addition to the Council of State, there has to be a technical body appointed under statute with non-departmental public body status, which can issue binding rulings in technical disputes, with very short procedural delays.展开更多
The administration of combination products in U.S.Food and Drug Administration(FDA)are analyzed and summarized in this paper.Furthermore,the technical evaluation on drug-medical device in the State Food and Drug Admin...The administration of combination products in U.S.Food and Drug Administration(FDA)are analyzed and summarized in this paper.Furthermore,the technical evaluation on drug-medical device in the State Food and Drug Administration of China(SFDA)is also illustrated.Meanwhile,this paper discusses how to promote the development of drug-medical device in the administration and technical evaluation.展开更多
文摘Based on this evidence and many other examples, this paper advocates a drastic overhaul of the system, in which a distinction is made between simple, standard projects, less simple solutions that can be assessed with performance requirements, and high-value projects which are handled in accordance with the science of probabilistics. Next to or in addition to the Council of State, there has to be a technical body appointed under statute with non-departmental public body status, which can issue binding rulings in technical disputes, with very short procedural delays.
文摘The administration of combination products in U.S.Food and Drug Administration(FDA)are analyzed and summarized in this paper.Furthermore,the technical evaluation on drug-medical device in the State Food and Drug Administration of China(SFDA)is also illustrated.Meanwhile,this paper discusses how to promote the development of drug-medical device in the administration and technical evaluation.
