论文部分内容阅读
本刊讯2015年12月31日,国家食品药品监督管理总局(CFDA)发布公告,要求相关企业和各地食品药品监管部门严格落实中药提取和提取物监督管理有关规定。针对中药提取环节存在的突出问题,CFDA于2014年7月印发了《关于加强中药生产中提取和提取物监督管理的通知》(食药监药化监〔2014〕135号,以下简称135号文件),明确了中药提取和提取物管理要求并规定了过渡期。公告要求,自2016年1月1日起,凡不具备相应提取能力
On December 31, 2015, the State Food and Drug Administration (CFDA) issued a public notice requiring relevant enterprises and food and drug regulatory authorities across the country to strictly implement the relevant provisions on the supervision and administration of extraction of Chinese herbs and extracts. In response to the prominent problems in the extraction of traditional Chinese medicines, the CFDA issued “Notice on Strengthening the Supervision and Administration of Extracts and Extracts from Traditional Chinese Medicine” (CFDA [2014] No. 135, hereinafter referred to as Document 135 ), Clear Chinese medicine extraction and extract management requirements and provides for the transitional period. Notice requirements, since January 1, 2016 onwards, where do not have the appropriate abilities