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实施临床前研究(GLP)、药品临床研究(CGP)管理将会是我国今后药品监督管理的重点之一,我国将用GCP认证逐步取代指定临床药理基地进行临床研究的现行做法。据悉,长期以来我国新药研制一直没有实施GLP、GCP规范,药物临床试验无监督管理,导致新药开发不规范现象时有发生。个别企业或研制者为了使新药尽快获得批准,竟然做假数据,提供假资料或抄袭别人的资料;仿制品种拿进口样品报验,导致自己生产的品种与报验品种质量指标存在很大差距;个别新药
The implementation of preclinical research (GLP) and drug clinical research (CGP) management will be one of the focuses of drug supervision and management in China in the future. China will use GCP certification to gradually replace the current practice of clinical pharmacology bases for clinical research. It is reported that for a long time China’s new drug development has not been implemented GLP, GCP norms, unsupervised management of drug clinical trials, resulting in the occurrence of non-standard development of new drugs. In order to get the new drug to be approved as soon as possible, individual companies or developers have to make false data, provide false information, or plagiarize other people’s data; imitation products take imported samples for inspection, leading to a large gap between the quality of the products they produce and the quality standards of the inspection products; Individual new drugs