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许多国家要求制药企业对与其产品有关的药物不良反应(ADRs)—通常包括严重的或未预料到的事件和反应要“迅速报告(Expoeitod Reporting)”.这种报告在时间选择上不像“立即(immedialbly)”不得延误(without delay)”那样有时限说明.在英国药物安全委员会(CSM)“立刻(forthwith)”是指自收到病例报告之日起不能迟于一个月内报告;在德国(联邦议院)“立刻(unverzuglich或immediate-ly)”被解释为“法定的不能耽误”;在澳大利亚“立刻”则被定义为72小时.近来,广泛的药品上市后监测工作的开展,迅速报告则被认为是在证实病例符合有关报告标准后的15个工作日之内报告所收集到的病例.但由于每个病例具有若干特征,而这些特征的表现及定义在不同国家之间常常是不同的,因此,使制药企业收集到的病例能否迅速报告和怎样迅速上报受到影响.
Many countries require pharmaceutical companies to report “adverse drug reactions (ADRs) related to their products - often including” serious or unexpected events and reactions “to” Expoeitod Reporting. “Such reports are less time-selective than the” immediate (immedialbly) “without delay.” The “forthwith” at the CSM means that no later than one month from the date of receipt of the case report should be reported; in Germany (Bundestag) “unverzuglich or immediate-ly” was interpreted as “statutory and can not be delayed” and “immediately” in Australia was defined as 72 hours. Recently, a wide range of drug post-marketing surveillance efforts have been reported quickly It is considered to report the cases collected within 15 working days after confirming that the cases meet the relevant reporting criteria.But because each case has several characteristics and the performance and definition of these characteristics are often different between different countries Therefore, it is affected whether the cases collected by pharmaceutical companies can be promptly reported and how quickly reported.