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889 result(s) found, displaying 526 to 550
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FormsThis checklist is to be used by sponsors to apply for priority review determination
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Reference materialNot everything that meets our definition of a biological is regulated as a biological
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Compositional guidelinesCompositional guideline for 'Streptococcus salivarius K12' permitted for use in listed medicines
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Reference materialApplication phases for a new registered complementary medicine
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Reference materialThe following instruments are made under section 22 of the Therapeutic Goods Act 1989
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Reference materialActive ingredient names section updated, following publication of Nomenclature of biological medicines consultation
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Reference material
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Reference materialThe new assessed listed medicines pathway is now available.
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User guideThis is a step-by-step guide for agents and sponsors who wish to apply for Priority review, Provisional determination or Orphan drug designation of a prescription medicine.
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Reference materialWatch this video to learn about invoicing, variations to CTNs and the Clinical Trial Repository.
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Reference materials23 instruments supporting the new COR process have been updated.
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Compositional guidelinesCompositional guideline for 'Larix arabinogalactan' permitted for use in listed medicines
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Reference materialPotential health risks and legal implications for placenta consumption
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Reference materialThe Scheduling Policy Framework (Scheduling Policy) sets out the national policy for applying access restrictions on medicines and chemicals.
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Compositional guidelinesCompositional guideline for 'Chicken comb extract' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'DHA/EPA rich Schizochytrium algal oil' permitted for use in listed medicines
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Reference materialWatch this video to learn about creating and submitting a Clinical Trial Notification (CTN) using the online form
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Reference materialThe NeeS specification is an interim arrangement as applicants plan the move to full eCTD
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FormsAdvisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS)
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Reference materialTGO 94 Standard for HPCs derived from Cord Blood has replaced TGO 75
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Reference materialUpdate to the six clinical evaluation streams and the functions each unit provides