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.
More information
- Good manufacturing practice: an overview
- Australian manufacturing licences and overseas GMP certification
- Manufacture of therapeutic goods
- Manufacturing principles & guidelines
- Manufacturing basics - Medicines and biologicals
- Inspection and audit feedback forms
- Webinar: Good Clinical Practice Inspection Program - 12 May
- SME Assist
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Access strategic plan: Updated for 2025-2028
The updated plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies. -
Consent relating to listed medicines that contain whole live microorganisms as an active ingredient
This consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989. -
Automatic extension of Mutual Recognition Agreement (MRA) Good Manufacturing Practice (GMP) clearances
MRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.
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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.