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623 result(s) found, displaying 176 to 200
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International scientific guidelines adopted in AustraliaCPMP/EWP/2330/99 adopted by the Therapeutic Goods Administration (TGA)
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/330418/2012 rev. 2.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/310834/2012 Rev. 1
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User guideFrom 14 September 2020, we will publish all notifications of shortages for reportable medicines on the Medicine Shortages Reports Database
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q8 (R2); EMA/CHMP/ICH/167068/2004
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S10; CHMP/ICH/752211/2012
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ICH S9 Q&As non-clinical evaluation for anticancer pharmaceuticals - Questions and answers (Step 2b)
International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S9 Q&As; EMA/CHMP/ICH/453684/2016 -
FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
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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 materialA step-by-step guide for Australian manufacturers of therapeutic goods.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/311805/2014.
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International scientific guidelines adopted in AustraliaCPMP/ICH/4106/00 adopted by the Therapeutic Goods Administration (TGA)
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Reference materialActive ingredient categories for medicinal cannabis products
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Reference materialThe Government has agreed to provide a 50 per cent reduction in annual charges for certain medical devices for the 2020-21 financial year.
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Reference materialOur approach to delays in overseas and Australian conformity assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/247713/2012
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/QWP/1401/98 Rev. 1/Corr **
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FormsThe 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.
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International scientific guidelines adopted in AustraliaCPMP/QWP/159/01, EMEA/CVMP/271/01 adopted by the Therapeutic Goods Administration (TGA)
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Reference materialUpdate to the conditions of approval on the ARTG for HIV POCT
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Reference materialA compositional guideline is a summary of descriptions, tests and limits that define the composition and characteristics of a substance approved for use in listed medicines as either an active substance or an excipient.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/488220/2012.
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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 – ICH E14; CHMP/ICH/2/04