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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 121 - 130 of 373

Overseas effective date: 23 Oct 2008

ICH Topic S1C (R2) - Note for Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceutical

Categories: Nonclinical | Toxicology | Carcinogenicity

Overseas effective date: 12 Dec 2017

ICH guideline Q4B Annex 10 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on polyacrylamide gel electrophoresis - general chapter

Categories: Quality | Specifications and analytical procedures and analytical validation

Overseas effective date: 12 Feb 2002

ICH Topic Q2 (R1) - Note for Guidance on Validation of Analytical Procedures: Text and Methodology

Categories: Quality | Specifications and analytical procedures and analytical validation

Overseas effective date: 12 Dec 2017

ICH guideline Q4B Annex 9 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on tablet friability - general chapter

Categories: Quality | Impurities | Quality | Specifications and analytical procedures and analytical validation

Overseas effective date: 1 Jan 1995

ICH Topic E 7 - Note for Guidance on Studies in Support of Special Populations: Geriatrics

Categories: Clinical efficacy and safety | General (clinical)

Overseas effective date: 15 Dec 2000

ICH Topic E 4 - Note For Guidance on Dose Response Information to Support Drug Registration

Categories: Clinical efficacy and safety | General (clinical)

Overseas effective date: 1 Aug 2000

Note For Guidance On Clinical Safety Data Management: Definitions And Standards For Expedited Reporting - Annotated with TGA comments

Categories: Clinical efficacy and safety | General (clinical) | Pharmacovigilance

Published: TGA News October 2000

Overseas effective date: 12 Feb 2002

ICH Topic E 1 - Note for Guidance on Population Exposure: The Extent of Population Exposure to Assess Clinical Safety

Categories: Clinical efficacy and safety | General (clinical)

Attention is drawn to:

  • Applicability, Section 7, which states that circumstances exist in which the Guidelines may not be applicable. It should be noted that the listing of exceptional circumstances is not exhaustive. Sponsors should give careful attention to whether, in any particular instance, the clinical safety of the product would be adequately supported by the numbers of subjects proposed, and;
  • Supplementary data, Section 8 is NOT ADOPTED. To permit decisions within legislated timeframes, the sponsor should include in the initial submission all clinical safety data necessary to support registration.

Overseas effective date: 29 Jun 2001

ICH Topic Q 6 A - Note for Guidance Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

Categories: Quality | Specifications and analytical procedures and analytical validation

Overseas effective date: 1 May 2000

ICH Topic Q 6 B - Note for Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Categories: Biological medicines | Drug substance | Specifications

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