What is regulated as a biological
What is regulated as a biological
Australian Regulatory Guidelines for Biologicals (ARGB)
Version 3.0, January 2020
Therapeutic Goods Administration
Copyright ? Commonwealth of Australia 2020 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to .
What is regulated as a biological V3.0 January 2020
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Therapeutic Goods Administration
Contents
Types of products regulated as biologicals _________ 4
How we define biologicals ____________________________________________________ 4 How we regulate biologicals _________________________________________________ 5
Excluded from TGA regulation ___________________ 6
Eligible autologous human cells and tissues products ___________________ 6 Fresh viable human organs___________________________________________________ 7 Fresh haematopoietic progenitor cells (HPCs) ____________________________ 7 Reproductive tissue for assisted reproductive therapy__________________ 7
Products regulated as a therapeutic good, but not as a biological _____________________________________ 8
Things that are not biologicals_______________________________________________ 8
Products regulated as biologicals _________________ 9
What is regulated as a biological V3.0 January 2020
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Therapeutic Goods Administration
This guidance is to help you understand what therapeutic goods will be regulated as a biological.
Is my product a therapeutic good? If you are new to the regulatory environment, we have developed a decision tool to help you decide if your product is a therapeutic good and if so, what type (medicine, medical device or biological): ? Is my product a therapeutic good?
Related information: Classification of biologicals
Types of products regulated as biologicals
Products that are regulated as biologicals include, but are not limited to: ? tissue-based products (skin, bone, ocular, cardiovascular, amnion) ? cell-based products (genetically modified, in vitro cell expansion or depletion) ? immunotherapy products containing human cells ? combination products (e.g. a cell therapy and a medical device) ? products that comprise or contain live animal cells, tissues or organs (e.g. pancreatic islet
cells isolated from pigs) ? autologous human cells and tissue products (including stem cells) ? faecal microbiota transplant(FMT) products (a thing that comprises, contains or is derived
from human stool)
How we define biologicals
For your product to meet our definition of a biological, it must be: ? a thing made from, or that contains, human cells or human tissues, and that is used to:
? treat or prevent disease, ailment, defect or injury ? diagnose a condition of a person ? alter the physiological processes of a person ? test the susceptibility of a person to disease ? replace or modify a person's body parts ? faecal microbiota transplant products ? a thing that comprises or contains live animal cells, tissues or organs
What is regulated as a biological V3.0 January 2020
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Therapeutic Goods Administration
How we regulate biologicals
Even though your product may meet the definition of a biological, it may not be regulated as a biological. You need to check if your biological is: ? Excluded from TGA regulation ? Regulated as a therapeutic good, but not as a biological ? Regulated as a biological
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