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

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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

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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

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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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