Standards and guidelines for prescription medicines

Registration process

• Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
  Guidelines to assist applicants and sponsors to register new prescription medicines or vary existing registrations in Australia including information about the Common Technical Document (CTD) format
• Early scientific advice
  Guidance on how to request Early Scientific Advice on a biowaiver justification
• Electronic submissions
  An electronic Submission (or eSubmission) is a set of registration files submitted in electronic form for the registration, or a variation to the registration, of a medicine
• Proposed new notifications process: registered medicines
  Guidance on proposed new notifications process for registered medicines to support anticipated changes to legislation
• Variations to prescription medicines – excluding variations requiring evaluation of clinical or bioequivalence data
  How to make variations to existing ARTG entries
• International scientific guidelines adopted in Australia
  Lists of European Union Guidelines relating to medicines, both those published as adopted in Australia and those published as not adopted in Australia
• Risk management plans (RMP)
  RMPs to be submitted for evaluation with certain higher-risk applications to enter a medicine or biological in the ARTG or to vary an ARTG entry
• Literature based submissions
  This document will assist sponsors in compiling a literature based submission (LBS)
• Evaluation Plan Estimators
  Before you lodge your pre-submission planning form (PPF) you can use the evaluation plan estimators to approximate the dates of the milestones in the prescription medicine registration process

Post-market monitoring

• Pharmacovigilance responsibilities of medicine sponsors
  This document sets out the pharmacovigilance responsibilities of sponsors of medicines included on the Australian Register of Therapeutic Goods (ARTG) and regulated by the TGA
• Electronic submission of individual case safety (adverse events) reports
  This document sets out how to use the TGA electronic data interchange for ICSR submission using the E2B R2 format
• Medicine shortages information
  Search for information about a medicine shortage and find out if there is a way to access an alternative product.
• Joint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance (PMS) studies
  These guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity

General information

• Australian Public Assessment Report (AusPAR) guidance
  Information about the structure, and processes for the compilation, review and publishing of an AusPAR
• Medicine labels: Guidance on TGO 91 and TGO 92
  Guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements
• Colourings used in medicines for topical and oral use
  Lists the colourings that may be used in topical and oral medicines, the regulatory and data requirements for new colourings
• Opioid reforms: Information for sponsors
  The TGA is implementing reforms to reduce harm to patients while providing continued access to this important class of medicines where it is medically necessary
• Naming ingredients
  Lists of Australian Approved terminology that ensure accuracy and consistency in the information compiled in the ARTG. For medicines, the lists cover substances (active ingredients and excipients), containers, dosage forms, routes of administration and units of expression and proportion.