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- Prescription medicines (335)
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771 result(s) found, displaying 176 to 200
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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Scientific Guideline - Data standards for drug and biological product submissions containing real-world data – Draft guidance for industry.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 AustraliaWe have adopted this International Scientific Guideline - Use of electronic health record data in clinical investigations – Guidance for industry.
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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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Reference materialThe TGA has investigated potential safety issues with complementary medicines with soft gel capsule dosage forms
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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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Reference materialThe permitted indication reform has now commenced
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Reference materialLearning modules for sponsors of listed medicines as a supplement to Evidence Guidelines.
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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 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 11; CHMP/ICH/730028/2009
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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 12; CHMP/ICH/730808/2009
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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 Q10; EMA/CHMP/ICH/214732/2007
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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.
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Reference materialSurgical mesh device supply disruption guidance for doctors and hospitals.
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Reference materialGuidance to assist sponsors and manufacturers comply with new regulations.
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FormsUse this form to make a freedom of information (FOI) request for a document held by the Therapeutic Goods Administration (TGA).
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User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) scheme Online System (SAS & AP online system) is the preferred method of submission for SAS applications and notifications.
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Reference materialFind out more about product standards that apply to unapproved therapeutic vapes for smoking cessation and the management of nicotine dependence.
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Compositional guidelinesCompositional guideline for Akkermansia muciniphila strain ATCC BAA-835 permitted for use in listed medicines.
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User guideThis document applies to all regulatory activities in electronic Common Technical Document (eCTD) format.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/608924/2014
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH M3 (R2 ) Q&As; EMA/CHMP/ICH/507008/2011