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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 111 - 120 of 373

Overseas effective date: 28 Sep 2011

Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products

Categories: Quality

Overseas effective date: 1 May 2016

Guideline on non-clinical local tolerance testing of medicinal products

Replaces: To replace: CPMP/SWP/2145/00 Note for Guidance on Non-Clinical Local Tolerance Testing of Medicinal Products

Categories: Nonclinical | Toxicology | Local tolerance

Overseas effective date: 15 Sep 2014

Questions and answers on the withdrawal of the 'Guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A)'

Categories: Nonclinical | Pharmacokinetics

Guideline 3BS11a has been withdrawn, as explained in the above Question and Answer Guideline; however, the guidance contained within Guideline 3BS11a remains applicable in Australia, as in the EU, and has been incorporated into TGA Guidance 23: Nonclinical studies.

Overseas effective date: 6 Apr 2009

Guideline on Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection

Categories: Nonclinical | Toxicology | Carcinogenicity

Overseas effective date: 27 Jan 2009

Guideline on the need for Non-Clinical Testing in Juvenile Animals of Pharmaceuticals for Paediatric Indications

Categories: Nonclinical | Toxicology | Reproductive and developmental toxicity

Overseas effective date: 1 Sep 2005

Guideline on the Evaluation of Control Samples in Nonclinical Safety Studies: Checking for Contamination with the Test Substance

Categories: Nonclinical | General (nonclinical)

Overseas effective date: 17 Dec 2010

Guideline on repeated dose toxicity

Categories: Nonclinical | Toxicology | Repeat-dose toxicity

Overseas effective date: 1 Aug 2014

Guideline on Real Time Release Testing (formerly Guideline on Parametric Release)

Replaces: CPMP/QWP/3015/99. Note for Guidance on Parametric Release (Adopted by TGA 22 May 2002)

Categories: Quality | Specifications and analytical procedures and analytical validation

Overseas effective date: 15 Sep 2014

Guideline on pharmaceutical development of medicines for paediatric use

Categories: Quality | Pharmaceutical development (quality)

Overseas effective date: 1 Dec 2014

Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 2: Defining the Scope of an NIRS Procedure

Categories: Quality | Specifications and analytical procedures and analytical validation

Prior approval by the TGA (e.g., via a Category 3 application) is necessary before implementation of any of the changes identified in Table 3 in this Addendum.