Manufacture a medicine
Regulatory responsibilities and expectations for medicine manufacturers.
Latest articles
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New quality standards for MDMA and psilocybine
Two new quality standards, one for MDMA and another for psilocybine, have been published. -
GMP surveillance inspections and extended validity of TGA GMP certificates
Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates. -
What you need to know about compounded weight-loss medicines
Some online health clinics are advertising and selling compounded medicines. However, it is important to know that compounded products are not identical to TGA approved products.
Events and webinars
Latest publications
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The TGA has published insights into recalls and GMP regulation for 2019-20.
Resources
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This guidance provides a summary of the changes in Good Manufacturing Practice (GMP) requirements resulting from the recent replacement of the PIC/S Guide to GMP for Medicinal Products (PE 009-15, 1 May 2021) with PE 009-16, 1 February 2022.
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Guidance for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
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Guidance on how to submit data in the electronic Common Technical Document (eCTD) format.
This webpage on the TGA website was printed on 14 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medicine