Topics
- Prescription medicines (74)
- Medicines (24)
- Over the counter medicine (13)
- Medical devices (10)
- Complementary medicines (9)
- Therapeutic goods regulation (7)
- Safety (6)
- Biological medicines (5)
- Electronic submissions (5)
- In Vitro Diagnostic medical devices (IVDs) (5)
- Shortages (5)
- Non-prescription medicines (4)
- Biologicals (3)
- Labelling and packaging (3)
- Regulatory compliance (3)
- Advisory bodies and committees (2)
- Import and export (2)
- Legislation (2)
- Scheduling (national classification system) (2)
- Assessed listed medicines (1)
- Australian Register of Therapeutic Goods (ARTG) (1)
- Clinical trials (1)
- Manufacturing (1)
- Medicinal cannabis hub (1)
- Other therapeutic goods (1)
Collection content
110 result(s) found, displaying 1 to 10
- GuidanceExport of medicines from AustraliaThis guidance is to assist with exporting medicines either for commercial supply, or for non-commercial purposes.
- GuidanceNotifications process: requests to vary registered medicines where quality, safety and efficacy are not affectedOutlines types of variations that have been determined to pose a very low risk.
- GuidanceMedicine shortages: Information for sponsors (suppliers)We have updated guidance on how to report medicine shortages to make the process clearer and easier to understand
- GuidanceReporting medicine shortages and discontinuations in Australia - Guidance for sponsorsWe have updated guidance on how to report medicine shortages to make the process clearer and easier to understand
- GuidanceSection 19A: Guidance for industryThe reference to the Quarantine Act 1908 in the Section 19A Guidance document has been replaced with reference to the Biosecurity Act 2015.
- GuidanceMedicine Shortages in Australia: Reporting obligations and the TGA's compliance frameworkGuidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations of supply of mostly prescription medicines
- FormsPre-submission Planning Form (PPF)The Pre-submission Planning Form (PPF) provides the TGA with the necessary information on the scope and scale of application to arrange appropriate resourcing for the processing and evaluation of an application.
- GuidanceEvaluation Plan EstimatorsThe evaluation plan estimators can be used to approximate the dates of the milestones in the prescription medicine registration process
- GuidanceGuidance 9: Therapeutic goods that contain or are produced from human blood or plasmaGuidance about the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma
- GuidanceGuidance 10: Adventitious agent safety of medicinesGuidance for sponsors of all medicines that contain, or are manufactured using materials of animal or human origin
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