You must comply with regulatory requirements when manufacturing biological products.
Biological products must be manufactured in compliance with recognised Good Manufacturing Practice (GMP) and product standards to ensure their quality, safety and efficacy.
These standards govern all aspects of production, testing, and release, with additional controls for biological variability and contamination risks.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about biologicals, and specific types of biologicals. You may also have to meet obligations that apply to 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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FormsThis form is for applicants of medicines and biologicals to request for a GMP pre-submission meeting.
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PageView published decisions relating to the granting of licences for the manufacture of therapeutic goods in Australia.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/572054/2016
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User guideThis page provides instructions on how to complete a statutory declaration to certify matters referred to in paragraph 38(1)(g) of the Therapeutic Goods Act 1989.
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PageLinks to information on good manufacturing practice (GMP), manufacturing inspections and manufacturer statutory declarations.
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PageThis section is for manufacturers of blood, blood components and HPCs
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GuidanceGuidance on when a manufacturing licence is required for manufacturing medicinal maggots and how a time-limited Goods Manufacturing Practice (GMP) exemption applies. Understand your regulatory obligations when producing medicinal maggot products in Australia.
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PageRegulatory requirements, principles, standards and record keeping apply to manufacturers of medicines and biologicals.
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PageView published decisions relating to the revocation of licences for the manufacture therapeutic goods in Australia.
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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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PageInformation on requesting a pre-submission meeting with the TGA for planned Good Manufacturing Practice (GMP) Licensing, Certification and Clearance applications.
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PageSponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers.
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PageView published decisions relating to the suspension of licences for the manufacture of therapeutic goods in Australia.
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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PageView published decisions relating to the granting of licences for the manufacture of therapeutic goods in Australia.
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User guideThis page provides instructions on how to complete a statutory declaration to certify matters referred to in paragraph 38(1)(g) of the Therapeutic Goods Act 1989.
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GuidanceGuidance on when a manufacturing licence is required for manufacturing medicinal maggots and how a time-limited Goods Manufacturing Practice (GMP) exemption applies. Understand your regulatory obligations when producing medicinal maggot products in Australia.
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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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PageView published decisions relating to the revocation of licences for the manufacture therapeutic goods in Australia.
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PageView published decisions relating to the suspension of licences for the manufacture of therapeutic goods in Australia.
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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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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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PageWe employ a risk-based approach to the frequency of manufacturer inspections.
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PageAll timeframes are variable depending on the cooperation of manufacturers, sponsors and sometimes international regulatory agencies
Product types