CAJ | 학술논문

药品注册是切实保障上市药品安全、有效和质量可控,保障公众用药安全的重要手段。在整个药品注册环节中,现场核查是注册工作的重点和核心之一。上海市食品药品监督管理局对已注册药品进行的两次核查,使我们对搞好药品注册现场核查工作的紧迫性和重要性有了更深刻的理解,同时也反映出我国当前的药品注册现场核查中存在的现实困境。我国应当借鉴其他国家的先进经验,从法律规制方面建立完善的药品注册现场核查员管理制度、建立统一细化的现场核查标准、规范核查的过程控制、完善核查方式和内容,这样才能达到切实保障上市药品的安全、有效和质量可控,保障公众用药安全的目的。
약품주책시절실보장상시약품안전、유효화질량가공,보장공음용약안전적중요수단。재정개약품주책배절중,현장핵사시주책공작적중점화핵심지일。상해시식품약품감독관리국대이주책약품진행적량차핵사,사아문대고호약품주책현장핵사공작적긴박성화중요성유료경심각적리해,동시야반영출아국당전적약품주책현장핵사중존재적현실곤경。아국응당차감기타국가적선진경험,종법률규제방면건립완선적약품주책현장핵사원관리제도、건립통일세화적현장핵사표준、규범핵사적과정공제、완선핵사방식화내용,저양재능체도절실보장상시약품적안전、유효화질량가공,보장공음용약안전적목적。
Drug registration is an important means to practically ensure that the drugs are safe,effective,and controllable.During the whole drug registration procedures,the on-site checking is one of the keys and core parts of registration.Shanghai Food and Drug Administration has examined the registered drugs twice to make us have deeper understanding of urgency and importance of undertaking the on-site examination of drug registration.Meanwhile,it reflects practical dilemma on the site-examination of drug registration.Therefore,our country should learn from other advanced countries,legally build and improve the checker management system of the on-site examination of drug registration,establish the identical and detailed on-site checking standards,regulate the checking process control,perfect the checking methods and contents as so to reach the goals of making sure that the medicine in the markets is safe,effective,and controllable in the quality.