Australian Agency Support to Make Your Job Easier

Regulatory guidelines and standards for Australia can be found here. The following links have been provided to further explain each of the listed subjects:

• Australian regulation of prescription medical products
• Australian regulatory guidelines for prescription medicines (ARGPM)
• European Union guidelines
• Approved terminology for medicines
• Colourings permitted in medicines for oral use
• Common technical document (CTD)
• Enforcement guidelines
• Guideline on product discontinuations
• Literature-based submissions - points to consider
• Pharmacovigilance & reporting adverse drug reactions
• Best practice guideline on prescription medicine labelling
• How long does it take to evaluate a prescription medicine?