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Collection content
111 result(s) found, displaying 1 to 10
- PublicationsJoint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance studiesThese guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity
- PublicationsLiterature based submissions
- GuidanceMicrobiological quality of medicinal cannabis productsNew guidance is available to assist sponsors and manufacturers of medicinal cannabis products to conform with TGO 100
- GuidanceProvisional determination eligibility criteriaUpdate to currency of data required for criteria assessment
- GuidanceProvisional registration processGuidance on provisional registration process for prescription medicines with provisional determination
- GuidanceProvisional registration extension and transition to full registrationGuidance now includes advice on lodgement of provisional variation applications
- GuidanceConflicts of interest and confidentiality obligationsGuidance for TGA advisory committees has been updated.
- GuidanceChild-resistant packaging requirements for medicines - Guidance on TGO 95New guidance document published to assist medicine sponsors in meeting the requirements for child-resistant packaging (TGO 95)