신약개발과 임상시험에 대한 미국 식품의약품청의 규제 법령에 관한 고찰

Abstract

Usually, it takes at least 8 years to develop new drugs. Especially, the clinical trials are required to spend about 5 years. In America, the whole steps for new drug development are provided thoroughly in statutes and regulations of FDA. Most of all, in this paper, I explored FDA’s regulations on the preclinical trials, Good Laboratory Practices, and FDA’s laws & regulations on the clinical trials that are the essential aspects in the new drug development. In order to protect the rights, safeties and welfares of the human research subjects in the clinical trials, FDA established very detailed provisions in the Code of Federal Regulations delegated by the relevant statutes. As mentioned earlier, FDA has exerted itself in recent years to ensure the safety as well as the speedy development of new drugs. The latter has been achieved by enacting PDUFA in 1992(now PDUFA IV from 2008 till 2012), the former is achieved by the thorough FDA regulations on the clinical trials. This paper consists of four chapters. Chapter Ⅰ describes the power of FDA on regulating the whole procedures of new drug development, the history of FDA’s laws and regulations on new drug development, and the purpose of this paper. Chapter Ⅱ examines the purpose, function, and contents of the preclinical trials and Good Laboratory Practices(GLPs). In addition, the methods of sanctions are explored when the clinical sponsor can not comply with the GLPs. Chapter Ⅲ reveals the details relating to the clinical trials. It includes the contents of Investigational New Drug Application(IND), Informed Consent, IRB, the phases of the clinical trials, sponsor’s collaboration with FDA regarding clinical trials, obligations of clinical sponsors and investigators, expanded access to investigational drugs, clinical hold, IND termination and suspension. Chapter Ⅳ summaries the above mentioned contents in the first half. In the second half, I suggest that the status of KFDA’s guidances is required to be enhanced to the status of C.F.R. in America because they are related to the protection of the rights, safeties and welfares of the human research subjects in clinical trials.