| 英文摘要 |
Regarding the safety and effectiveness of drugs, it is a basic requirement for the approval of a NDA/ANDA/BLA, beneficial to protect the health of the people and reduce their property expenses. To this end, all the national legislations and the authoritues of drug administrations in the world have stipulated strict legal requirements for the approval of new drug listings and strict law and specifications to regulate a IND/NDA/ANDA/BLA filed by a spnsor/applicant respectively and govern the FDA to review and approve. Among them, the judgment on the effectiveness of drug is the core problem in the whole field of pharmaceutical law. This article tries to explore the American legal system as the basis and the guidelines published by ICH as the latitude. From the normative, industrial and scientific aspects, it discusses the relevant issues concerning how to approve a NDA and ANDA in U.S.A., and clarifies the connotation of effectiveness of the drug. For example, from the industrial perspective, how the pharmaceutical industry regulates and designs the drug will have the effect it purports or is represented to have and its relationship with the effectiveness of the drug; from the normative aspect, this article will elucidate the content, composition and quantity of substantial evidence to prove the effectiveness of the drug, including adequate and well-controlled investigations/trials, and gold standards for randomized, blinded, and controlled trials; from the scientific aspect, this article will explore the design of trials of how to demonstrate the effectiveness of drugs (e.g., significance trial, superiority trial, equivalence trial, and non-inferiority trial etc.), and the meanings of the statistical significance, clinical significance, how to test or measure? how to become a element of legal requirement for the effectiveness of drug? and their applicable disputes in the drug administration and judicial practice, expecting more comprehensively to understand the connotation of effectiveness of the drug, clarify the relevant doubts in the field, and enrich the research energy in the field of pharmaceutical law in Taiwan (R.O.C.) and will help the latecomers. |
