CAJ | 학술논문

FDA在新药研究申请和新药申请中所积淀的成功监管经验值得借鉴，我国相对宽泛的“新药申请”不利于行政监管资源的优化配置，可将“三改药品”改为“仿制药申请”程序或取消其市场定价权；从新药申请的安全性和有效性应优先于经济行政的角度，“形式审查”、“现场核查”可统一由国家药监局统一行使，同时要加强技术审评队伍建设，增加国家级评审人员和财政投入；在行政许可法框架内，建立评审机构与申请人之间的合作、交流、沟通的具体技术审评制度，加强对新药审评的行政指导和“过程性”监督，在确保新药上市的安全有效性的前提下缩短其上市周期。
FDA재신약연구신청화신약신청중소적정적성공감관경험치득차감，아국상대관범적“신약신청”불리우행정감관자원적우화배치，가장“삼개약품”개위“방제약신청”정서혹취소기시장정개권；종신약신청적안전성화유효성응우선우경제행정적각도，“형식심사”、“현장핵사”가통일유국가약감국통일행사，동시요가강기술심평대오건설，증가국가급평심인원화재정투입；재행정허가법광가내，건립평심궤구여신청인지간적합작、교류、구통적구체기술심평제도，가강대신약심평적행정지도화“과정성”감독，재학보신약상시적안전유효성적전제하축단기상시주기。
FDA's regulatory experience in new drug research and new drug application is worth learning. The broad application for new drugs in China is not conducive to the optimal allocation of administrative supervision resources. “Sangai drugs” should be changed to the program of generic application or their market pricing should be canceled;From the perspective that the safety and effectiveness of the application for new drug should precedence over economic administration, National Bureau of Drugs Supervision is responsible for“formal examination” and “on-site verification”, and at the same time, the construction of technical evaluation team should be strengthened and the investment of national reviewers and finance should be increased; Under the framework of Administrative Licen-sing Law, the concrete evaluation system such as cooperation, exchange and communication between appraising organizations and appli-cants should be established and the administrative guidance and process supervision on examination for new drugs should be strength-ened, trying to shorten product manufacturing period under the premise of ensuring the safety and effectiveness of new drugs.