The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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- Advanced therapies (2)
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277 result(s) found, displaying 76 to 100
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GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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GuidanceGuidance about the types of notifications and variations for biological medicines.
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GuidanceGuidance on our approved terminology for medicines.
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GuidanceGuidance on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).
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GuidanceGuidance for sponsors on the process for including IVD medical devices in the ARTG.
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GuidanceGuidance on the transitional arrangements and obligations of medical devices with a diagnostic function.
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GuidanceGuidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.
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GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
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GuidanceGuidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.
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GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
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GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).
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GuidanceThis guidance explains requirements for registering a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance to understand if your medical device product should be in the ARTG.
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GuidanceGuidance on the use of modified unprocessed herbal materials in complementary medicines
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GuidanceGuidance for making an offer of enforceable undertaking to us.
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GuidanceGuidance on using literature based submissions for applications for listed, assessed listed and registered complementary medicines.
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GuidanceGuidance for sponsors about how to apply for orphan drug designation for a prescription medicine.
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GuidanceGuidance on the application process and information required for a substance to be evaluated for use in listed medicines.
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GuidanceOTC medicine monograph guidance: Topical nasal decongestants.
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GuidanceOTC medicine monograph guidance: Bromhexine hydrochloride.
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GuidanceGuidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.
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GuidanceGuidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.
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GuidanceGuidance for biological sponsors on the eligibility criteria and supporting documents required for priority determination applications
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GuidanceGuidance on submitting the CPD for prescription medicines.