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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 41 - 50 of 373

Overseas effective date: 1 Apr 2014

Guideline on Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application (Revision)

Replaces: CPMP/VEG/4717/03 (Adopted by TGA 16 August 2004)

Categories: Biological medicines | Drug substance | Multidisciplinary | Vaccines (multidisciplinary) | Nonclinical | General (nonclinical)

Section 1.1.2. Pandemic variation

If the pandemic influenza virus is of a HN subtype for which nonclinical and clinical data have not been included in the Core Pandemic Dossier, it is highly desirable that nonclinical and clinical data obtained from studies with the pandemic HN subtype be included in the pandemic variation dossier.

Section 3.1.1

Candidate influenza vaccine virus should be taken to include the most recently available candidates and technologies, as noted on WHO website.

Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.

The nonclinical and clinical aspects of this Guidelines continue to apply.

Overseas effective date: 1 Jul 2005

Guideline on Adjuvants in Vaccines for Human Use

Categories: Biological medicines | Drug substance | Vaccines (drug substance) | Multidisciplinary | Vaccines (multidisciplinary)

Overseas effective date: 24 Feb 2014

Questions and answers on the withdrawal of the 'Note for guidance on single dose toxicity'

Replaces: 3BS1a Single Dose Toxicity

Categories: Nonclinical | Toxicology | Single-dose toxicity

Overseas effective date: 1 Apr 2006

Guideline on the Non-Clinical Documentation for Mixed Marketing Authorisation Applications

Categories: Nonclinical | General (nonclinical)

Overseas effective date: 1 May 2000

Note for Guidance on Pre-Clinical Pharmacological and Toxicological Testing of Vaccines

Categories: Nonclinical | General (nonclinical)

Overseas effective date: 1 May 2009

Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents

Categories: Quality | Impurities | Nonclinical | General (nonclinical) | Clinical efficacy and safety | General (clinical)

Overseas effective date: 24 Feb 2014

Questions and answers on the 'Guideline on the limits of genotoxic impurities'

Replaces: EMA/CHMP/SWP/431994/2007 Revision 2

Categories: Quality | Impurities | Nonclinical | Toxicology | Genotoxicity

For information: 24 February 2014

Overseas effective date: 4 Sep 2002

Points to Consider on the Non-Clinical Assessment of the Carcinogenic Potential of Insulin Analogues

Categories: Nonclinical | Toxicology | Carcinogenicity

Overseas effective date: 5 Mar 2003

Note for Guidance on Carcinogenic Potential

Categories: Nonclinical | Toxicology | Carcinogenicity

Overseas effective date: 1 Feb 2018

Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence

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