Extract from the Clinical Evaluation Report for etanercept ：从依那西普临床评估报告提取物.docxVIP

Date of first round CER: 31 May 2013Date of second round CER: 15 October 2013AusPAR Attachment 2Extract from the Clinical Evaluation Report for etanercept (rch)Proprietary Product Name: EnbrelSponsor: Pfizer Australia Pty LtdAbout the Therapeutic Goods Administration (TGA)The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices.The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet