외국(外國)의 의약품허가신청첨부자료(醫藥品許可申請添付資料) 및 자문기구(諮問機構)의 현황(現況) ( I )

Status of Worldwide Regulations on Scientific Data for the Registration of Drugs for Human Uses & Advisory Committees(I)

A comparison of worldwide drug registration requirements on scientific data required by the different regulatory authorities for the investigational new drug and new drug application for human uses was briefly reviewed and as one of administrative processings on review and evaluation of applications, the functions of scientific advisory committees were reviewed.