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771 result(s) found, displaying 151 to 175
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q9; EMA/CHMP/ICH/24235/2006
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S1; EMA/CHMP/ICH/752486/
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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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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S6 (R1); EMA/CHMP/ICH/731268/1998
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH M4E (R2); EMA/CPMP/ICH/2887/1999
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E10; CPMP/ICH/364/96
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E1; CPMP/ICH/375/95
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S5 (R3); EMA/CHMP/ICH/544278/1998
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 8; EMA/CHMP/ICH/645592/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 6; CHMP/ICH/645408/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 7 (R2); EMA/CHMP/ICH/645469/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 9; EMA/CHMP/ICH/379801/2009
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 4C; EMA/CHMP/ICH/308867/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 3; EMA/CHMP/ICH/561176/2007
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 4B; EMA/CHMP/ICH/308817/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 4A; EMA/CHMP/ICH/308671/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH Q4B Annex 13; CHMP/ICH/405290/2010
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Reference materialThe Australian Regulatory Guidelines for Medical Devices (ARGMD) is an index of Guidance.
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Reference materialThis guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.
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Reference materialWe review the Permissible Ingredients Determination to ensure the ingredients are safe for use in low-risk medicines.
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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 - 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 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 - Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products.