You must comply with regulatory requirements when manufacturing human cell and tissue products.
The procurement, collection or manufacture of human tissue or human cell products must be compliant with Good Manufacturing Practice (GMP) and meet product standards to ensure their quality, safety and efficacy.
We regulate these activities to protect public health and ensure human cell and tissue products remain safe and effective.
If you import or export human cell and tissue products, you must comply with Australian laws.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to biologicals. You may also have to meet obligations that apply to all biologicals and all products.
Good Manufacturing Practice
Understand the standards for Good Manufacturing Practice.
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PageThe Code applies to blood, human tissues and human cellular therapy products manufacturers.
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PageGood Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.
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PageInformation on complying with good manufacturing practice (GMP).
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PageLinks to information on good manufacturing practice (GMP), manufacturing inspections and manufacturer statutory declarations.
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PageInformation on manufacturing biologicals, blood and tissues and advanced therapies.
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PageThis section is for manufacturers of blood, blood components and HPCs
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GuidanceGuidance to help work out if your autologous HCT product is excluded from our regulation.
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GuidanceGuidance to help work out if your autologous HCT product is exempt from some aspects of our regulation.
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PageRegulatory requirements, principles, standards and record keeping apply to manufacturers of medicines and biologicals.
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GuidanceGuidance on good manufacturing practice (GMP) compliance requirements for domestic and overseas manufacturers of medicines and biologicals.
GMP clearance
Access information on applying for GMP clearance.
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PageSponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers.
Licensing
Find out how to apply for, vary or maintain a manufacturing licence.
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PageThere is an annual charge for the manufacturing of therapeutic goods.
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PageA step-by-step guide to assist Australian manufacturers of therapeutic goods apply for a Good Manufacturing Practice (GMP) licence.
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User guideA step-by-step guide for Australian manufacturers of therapeutic goods.
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PageA step-by-step guide for Australian manufacturers of therapeutic goods (other than medical devices) applying to vary a manufacturing licence.
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PageThis guidance is for Australian manufacturers who wish to transfer a manufacturing licence to another entity.
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PageVary your Good Manufacturing Practice (GMP) clearance or licence.
Certification
Access information on applying for or varying certification.
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User guideA step-by-step guide for Australian manufacturers of therapeutic goods.
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PageThis information is for Australian sponsors or agents of Australian sponsors of overseas manufacturers making GMP certification applications.
Inspections
Learn how TGA conducts inspections of manufacturing sites.
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PageWhen we inspect a manufacturer for compliance with GMP, we assess your level of compliance with the manufacturing principles and any other requirements (such as TGOs and conditions of authorisation)
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PageWe regularly inspect manufacturers of medicines and biologicals, using a risk-based approach, to ensure compliance with manufacturing principles.
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PageA manufacturer's compliance level is determined by the number and nature of deficiencies found during inspections, and their response to the inspection report.
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PageManufacturers of therapeutic goods are regularly inspected to ensure compliance with manufacturing principles.
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PageWe employ a risk-based approach to the frequency of manufacturer inspections.
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PageManufacturer inspections and their frequency are guided by the inherent risks of a product.
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PageManufacturers of therapeutic goods are regularly inspected by the TGA using a risk-based approach to ensure compliance with GMP standards.
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PageAll timeframes are variable depending on the cooperation of manufacturers, sponsors and sometimes international regulatory agencies