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关于细胞疗法的实践规范、标准化方法和法规的新指南。

New guidance on codes of practice, standardized methods and regulations for cell-based therapeutics.

作者信息

Harris Neil, Munro Caroline, Patel Bhavisha

机构信息

LGC Limited, Teddington, Middlesex, UK.

出版信息

Regen Med. 2006 Sep;1(5):705-7. doi: 10.2217/17460751.1.5.705.

Abstract

Consultations with members of the UK regenerative medicine community have identified the need for greater overall clarity regarding the current legislation, guidance and standards to be used. To facilitate this, the UK Department of Trade and Industry commissioned the British Standards Institution to develop guidance on the product pathway from cell/tissue donation to clinical trial for cell-based therapies within the UK and outline the accompanying legislation, codes of practice, guidance documents and standards for this process. This document will be aimed at a cross-section of end users from academic groups through to small and medium enterprises, larger industrial companies and the general public.

摘要

与英国再生医学领域的成员进行磋商后发现,需要对现行立法、指南和使用的标准有更全面清晰的认识。为推动此事,英国贸易和工业部委托英国标准协会制定关于英国境内基于细胞疗法从细胞/组织捐赠到临床试验的产品路径指南,并概述该过程的相关立法、实践守则、指导文件和标准。本文件的目标受众广泛,包括从学术团体到中小企业、大型工业公司以及普通公众等各类终端用户。

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