You are here

International scientific guidelines adopted in Australia

5 August 2020

The TGA closely aligns its regulatory approaches to therapeutic products with those of comparable international regulatory counterparts wherever possible.

Technical data requirements for applications to register or vary the registration of medicines in Australia are closely aligned with requirements set out in relevant:

  • European Union (EU) Guidelines
  • Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • Food and Drug Administration (USA)

International Guidelines are not limited to prescription medicines, but may also apply to OTC, complementary and some listed medicines. It is important that you review the relevant guidelines that are adopted in Australia prior to manufacturing and supplying a medicine.

While guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements and any deviation from a Guideline relevant to an application to register or vary the registration of a medicine must be justified.

Prior to adopting any Guideline, the TGA undertakes an extensive process of internal and external consultations to ensure the Guideline is consistent with prevailing requirements in Australia. TGA publishes a searchable list of International Guidelines adopted in Australia. Please check for current consultations on proposed guidelines for adoption in Australia.

Please note: Where EU Guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.

International scientific guidelines adopted in Australia

Displaying 101 - 110 of 373

Overseas effective date: 10 Aug 2005

ICH Topic E 2 E - Note for Guidance on Planning Pharmacovigilance Activities

Categories: Pharmacovigilance

Overseas effective date: 12 Dec 2017

ICH guideline Q4B Annex 3 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination: subvisible particles general chapter

Categories: Quality | Specifications and analytical procedures and analytical validation

Overseas effective date: 12 Dec 2017

ICH guideline Q4B annex 2 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter

Categories: Quality | Specifications and analytical procedures and analytical validation

Overseas effective date: 21 Jul 2014

ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER)

Replaces: CPMP/ICH/4679/02. Clinical Safety Data Management - Periodic Safety Update Reports for Marketed Drugs (Addendum to ICH E2C - CPMP/ICH/288/95) (Adopted by TGA 7 June 2005)

Categories: Pharmacovigilance

Overseas effective date: 10 Jan 2002

ICH Topic S 7 A - Note for Guidance on Safety Pharmacology Studies for Human Pharmaceuticals

Categories: Nonclinical | Pharmacology

Overseas effective date: 10 Nov 2014

ICH guideline Q4B - Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests - general chapter

Categories: Quality | Specifications and analytical procedures and analytical validation

ICH guideline M3 (R2) - questions and answers

Categories: Nonclinical | Pharmacology | Multidisciplinary | Miscellaneous

For information: 1 June 2014

Overseas effective date: 25 Feb 2009

ICH Topic E15 - Note for Guidance on Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories

Categories: Multidisciplinary | Pharmacogenomics

Overseas effective date: 1 Apr 2014

ICH guideline E3 - questions and answers (R1)

Categories: Clinical efficacy and safety | General (clinical)

Overseas effective date: 24 Feb 2014

ICH guideline S2 (R1) on genotoxicity testing and data interpretation for pharmaceuticals intended for human use

Replaces: Replaces and combines CPMP/ICH/141/95 (ICH S2A) and CPMP/ICH/174/95 (ICH S2B)

Categories: Nonclinical | Toxicology | Genotoxicity

Pages