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  • 24 September 2014
    The Pre-submission Planning Form (PPF) provides the TGA with the necessary information on the scope and scale of application to arrange …
  • 15 September 2014
    Introduction

    This guidance is to assist sponsors with submitting nonclinical studies in Module 4 of the Common Technical Document (CTD) as part of the application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG). This guidance is in addition to the...

  • 16 June 2014

    The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopted by the Therapeutic...

  • 27 May 2014
    Why do a systematic literature...
  • 27 May 2014

    The TGA guidance on literature based submissions has been updated.

    The purpose of this guidance is to assist applicants compile a literature based submission (including mixed applications), and replaces the previous TGA guidance: Literature-Based...

  • 27 May 2014

    This guidance describes the format of literature based submissions and applies to applications based on a systematic search of the literature and those not based on a systematic search of the literature.

    What format is required for literature based submissions? Where can I use literature...
  • 27 May 2014
  • 26 May 2014

    A 'fixed combination' medicine contains more than one active ingredient.

    The active ingredients may be present as:

    separate entities a mixture in a chemical combination which is intended to degrade into the active components in vivo .

    They may be either:

    in the same dose...
  • 26 May 2014

    When medicines are under development, it is a general rule that the patients entering clinical trials should be reasonably representative of the population that will be later treated by the medicine.

    The use of medicines in some populations (e.g. paediatric or the elderly) requires...

  • 7 May 2014

    Picture of the cover of this publication

    This document TGA Approach to disclosure of commercially...

  • 9 August 2013

    This guidance provides sponsors with the information requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).

    Contents Impurities in drug substances and drug products Related impurities in drug substances and drug products...
  • 9 August 2013

    This guidance is intended for manufacturers of drug substances for prescription medicines, and sponsors of prescription medicines sourcing drug substances from a third party manufacturer.

    Contents Drug Master Files and Certificates of Suitability What substances require a Drug Master File...
  • 31 July 2013
    8.1 What is product information

    The PI is a document...

  • 12 July 2013
    Introduction

    This information is intended for sponsors applying to the TGA to enter a radiopharmaceutical in the Australian Register of Therapeutic Goods (ARTG).

    Contents What are radiopharmaceuticals Product information for radiopharmaceuticals Cyclotron-produced radiochemicals Products...
  • 12 July 2013
    Introduction

    This information applies to prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).

    It does not apply to cell-based and tissue-based therapies that are defined as biologicals in the Therapeutic Goods Act 1989 and its amendments, and...

  • 12 July 2013
    Introduction

    This guidance:

    outlines the types of fees for services that apply to the registration of prescription medicines, and the variation of existing registrations. provides an overview of the various types of applications to do with prescription medicines. explains when payments are...
  • 12 July 2013
    Introduction

    This guidance is intended for sponsors who are submitting the Certified Product Details (CPD) for their prescription medicine to the TGA.

  • 12 July 2013
    The submission dossier checklist is not mandatory for the submission of applications, however it can be used to assist you to standardise …
  • 25 June 2013
    This proforma is to be used by sponsors to prepare certified product details (CPD) for chemical prescription medicines when requested by …
  • 3 June 2013
    Module 1 Category 1/category 2 applications - Module 1 TGA's application fee type is … A - NCE B - New Combination C...
  • 3 June 2013
    Module 2 Category 1/2 applications, fee type A, B C and D Module 2 Category 1/2 applications, fee type E, F and J Module 2 Category 3 applications, fee type G and H Module 3-5 Category 1/2 applications, fee type A, B C and D Module 3-5 Category 1/2 applications, fee type E, F and J Module 3-5...