Wall D M P, Prince H M
Centre for Blood Cell Therapies, Peter Mac Callum Cancer Centre, Melburne, Victoria, Australia.
Cytotherapy. 2003;5(4):284-8. doi: 10.1080/14653240310002207.
The first step in the process of regulating cell-based products in Australia was taken in 1991, when the code of good manufacturing practice (cGMP) for 'Blood and Blood Components' was instituted. Paradoxically, it focused on the regulation of plasma fractionation, the non-cellular component of blood. Subsequently, Australia's regulatory body for medicinals, the Therapeutic Goods Administration (TGA), has clearly stated that all cell-based therapies utilizing components of blood and/or tissues will be regulated. The final landscape for the regulation of cellular therapies has yet to be defined, but is likely to be clarified within the next 12 months. The current cGMP for 'Blood and Tissues' is the regulatory document for all aspects of cell processing, including standard blood components (cellular and plasma), cord blood and allogeneic cells for storage. Currently, there are some exemptions to government regulation, and the most important of these is autologous hemopoietic stem cells (HSC). Indeed, no licensing is required for processing of HSC at the moment, although most centers subject themselves to a self-imposed auditing system through the National Association of Testing Authorities, Australia. However, it is anticipated that within 12 months this and the other exemptions within the Act will be removed. The TGA will become the formal regulator of all cell-based therapies, and laboratories will be required to apply for cGMP auditing and licensing. It is likely that the Foundation for the Accreditation of Cellular Therapy (FACT) guidelines or others of a similar nature, will form the basis of one of the regulatory standards for HSC processing. Of particular note is the inclusion of apheresis as an integral component of cGMP licensing.
澳大利亚对细胞产品进行监管的第一步始于1991年，当时制定了“血液及血液成分”的良好生产规范（cGMP）。矛盾的是，它侧重于对血浆分离的监管，即血液的非细胞成分。随后，澳大利亚药品监管机构——治疗用品管理局（TGA）明确表示，所有利用血液和/或组织成分的细胞疗法都将受到监管。细胞疗法监管的最终格局尚未确定，但可能会在未来12个月内得到明确。目前的“血液和组织”cGMP是细胞处理各个方面的监管文件，包括标准血液成分（细胞和血浆）、脐带血以及用于储存的异体细胞。目前，政府监管存在一些豁免情况，其中最重要的是自体造血干细胞（HSC）。事实上，目前处理HSC无需许可，尽管大多数中心通过澳大利亚国家测试机构协会自行实施审核制度。然而，预计在12个月内，这一情况以及该法案中的其他豁免将被取消。TGA将成为所有细胞疗法的正式监管机构，实验室将需要申请cGMP审核和许可。细胞治疗认证基金会（FACT）指南或其他类似性质的指南，很可能会成为HSC处理监管标准之一的基础。特别值得注意的是，单采被纳入cGMP许可的一个组成部分。
