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623 result(s) found, displaying 151 to 175
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH S9; EMA/CHMP/ICH/646107/2008
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/457920/2012 rev 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CAT/80183/2014
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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 9; EMA/CHMP/ICH/379801/2009
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Reference materialExplanatory guide on the quality modules to be submitted for influenza vaccine registration, for manufacturers and sponsors.
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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 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 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 4C; EMA/CHMP/ICH/308867/2008
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Reference materialA resource for sponsors conducting market actions for therapeutic goods in Australia.
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Reference materialThe TGA has initiated compliance reviews of a selection of listed medicines at risk of containing safrole
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E14 Q&As; EMA/CHMP/ICH/310133/2008
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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 – ICH M4E (R2); EMA/CPMP/ICH/2887/1999
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/VWP/164653/2005.
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User guideA guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications.
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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 materialUpdate to Stability testing of prescription medicines
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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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FormsA revised CPD template for Biological medicines and vaccines is now available for sponsors
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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 materialWe review the Permissible Ingredients Determination to ensure the ingredients are safe for use in low-risk medicines.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BMWP/403543/2010
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International scientific guidelines adopted in AustraliaCPMP/BPWG/2220/99 adopted by the Therapeutic Goods Administration (TGA)