Manufacturing
Information to assist manufacturers understand their regulatory responsibilities, including licensing.
In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence or a conformity assessment certificate.
It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence or a conformity assessment certificate unless the manufacturer or goods are exempt from this requirement.
Only Australian manufacturing sites can obtain a manufacturing licence.
Overseas manufacturers can instead obtain GMP certification following a successful on-site inspection by the TGA.
GMP certification applications are required to be submitted by the Australian sponsor or an agent acting on the Australian sponsor's behalf.
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Manufacturing basics: medicines and biologicals
Links to information on good manufacturing practice (GMP), manufacturing inspections and manufacturer statutory declarations. -
Manufacture of therapeutic goods
Manufacture of therapeutic goods is defined differently depending on the type of therapeutic goods. -
Manufacturer inspections: an overview
Manufacturers of therapeutic goods are regularly inspected by the TGA using a risk-based approach to ensure compliance with GMP standards. -
Make a statutory declaration
Information on when statutory declarations are required by the Therapeutic Goods Administration (TGA).
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Declaration of intent to supply the Australian market
This information is for Australian sponsors or agents of Australian sponsors of overseas manufacturers making GMP certification applications. -
Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence
As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS. -
Data Management and Data Integrity (DMDI)
Clarification regarding the TGA's position regarding DMDI practices for industry. -
Notices for manufacturers
These notices are for manufacturers of medicines, biologicals and blood, blood components and HPCs.
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Manufacture a medical device
Regulatory responsibilities and expectations for manufacturers of medical devices, including in vitro diagnostics (IVDs). -
Manufacturing biologicals, blood and tissues and advanced therapies
Information on manufacturing biologicals, blood and tissues and advanced therapies. -
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List of licensed manufacturers in Australia
Instructions for searching Australian manufacturers licensed for the manufacture of medicines, blood and biologicals.
Good manufacturing practice
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Good manufacturing practice: an overview
Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality. -
GMP clearance Sponsor Information Dashboard (SID)
Information about current processing times, workload, priorities, and key messages for GMP Clearance applications. -
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How to obtain GMP clearance through inspection reliance
Find out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
Latest alerts
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Product Alert: Australasian Medical & Scientific Ltd (AMSL), the sponsor of the t:slim X2 insulin pump, has identified that certain versions of the device have a wiring problem with the speaker.
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Product Correction: Some K Care Seat Walkers have been supplied without a complete User Manual.
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Weleda Australia Pty Ltd is recalling one batch of Weleda Baby Teething Powder following a complaint that a fragment of glass was found in one bottle of this product.
Latest articles
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Changes to the Prescription Medicines Minor Variation (PMMV) form
We will implement process enhancements to the Prescription Medicines Minor Variation (PMMV) form by 31 January 2026. -
IMDRF Consultation on Predetermined Change Control Plans (PCCPs)
The International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) Working Group has published the draft Essential Principles and Content of Predetermined Change Control Plans document for public consultation. -
Nitrosamine impurities acceptable intakes update - November 2025
The TGA is updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI).
Latest publications
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A meeting statement from the second meeting of the Point-of-care Manufacturing of Medical Devices Steering Committee is now available.
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A meeting statement from the first meeting of the Point-of-care Manufacturing of Medical Devices Steering Committee is now available.
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The guidelines set out the criteria which must be met for any additional manufacturing sites to be included as secondary sites on new or existing manufacturing licences.