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889 result(s) found, displaying 1 to 25
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Reference materialThis road map presents an overview of the requirements for supplying an IVD for Australian sponsors.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Considerations for the inclusion of adolescent patients in adult oncology clinical trials - guidance for Industry.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products.
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International scientific guidelines adopted in AustraliaWe have adopted this draft International Scientific Guideline - Data standards for drug and biological product submissions containing real-world data – Draft guidance for industry.
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International scientific guidelines adopted in AustraliaThe general principles of this guideline are adopted. Please note that any references to FDA processes are not applicable in submissions to the TGA.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Submitting documents using real world data (RWD) and real-world evidence (RWE) to FDA for drugs and biologics.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - Use of electronic health record data in clinical investigations – Guidance for industry.
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Reference materialThe TGA has investigated potential safety issues with complementary medicines with soft gel capsule dosage forms
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Reference materialSerious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.
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Reference materialThe TGA has published updated Australian Regulatory Guidelines for Sunscreens
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User guideThe system now allows equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the ARTG
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User guideThis user guide will assist you in providing the required information for completing (and submitting) an application for an assessed listed medicine (either for new ARTG entries or changes to existing ARTG entries)
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Reference materialUpdated frequently asked questions to inform sponsors about discontinuing the pre-market evaluation of HCNs.
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Reference materialWe have implemented a Compliance Rating Scheme for listed medicines as part of ongoing enhancements to our post-market compliance monitoring program
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Reference materialLearning modules for sponsors of listed medicines as a supplement to Evidence Guidelines.
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Reference materialThe permitted indication reform has now commenced
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Reference materialThe TGA has published guidance material on the TGA efficacy claim
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International scientific guidelines adopted in AustraliaWe have adopted this international Scientific Guideline – ICH Q4B Annex 1; EMA/CHMP/ICH/222063/2006
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 10; EMA/CHMP/ICH/381133/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 11; CHMP/ICH/730028/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 12; CHMP/ICH/730808/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q10; EMA/CHMP/ICH/214732/
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q8, Q9 & Q10 Q&As (volume 4); EMA/CHMP/ICH/265145/2009
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User guideStep by step guide to submitting a Custom-Made Medical Device (CMMD) notification.