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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 81 - 90 of 373

Overseas effective date: 16 Jun 2004

Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products

Replaces: CPMP/QWP/122/02 and CPMP/QWP/556/96

Categories: Quality | Stability

Overseas effective date: 15 Dec 2000

Decision Trees for the Selection of Sterilisation Methods (Annex to CPMP/QWP/155/96)

Categories: Quality | Pharmaceutical development (quality)

Quality of medicines Q&A

Categories: Quality | Q and A on quality

Answers amended after 1 August 2014 are excluded until such time as they have been considered by TGA.

For information: 1 August 2014

Overseas effective date: 21 Jul 2014

Guideline on Conduct of Pharmacovigilance for Medicines Used by the Pediatric Population

Replaces: EMEA/CHMP/PhVWP/235910/2005 (adopted by TGA 16 March 2009)

Categories: Multidisciplinary | Paediatrics | Pharmacovigilance

Overseas effective date: 29 Jun 2009

Reflection Paper on Pharmacogenomic Samples, Testing and Data Handling

Categories: Multidisciplinary | Pharmacogenomics

Reflection Paper: Formulations of Choice for the Paediatric Population

Categories: Multidisciplinary | Paediatrics

For information: 29 June 2009

ICH guideline Q3C (R5) on impurities: guideline for residual solvents

Replaces: CPMP/ICH/283/95. ICH Topic Q3C (R4) (Adopted by TGA 1 June 2014)

Categories: Quality | Impurities | Nonclinical | General (nonclinical)

Overseas effective date: 1 Aug 2014

ICH guideline S1 Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals

Categories: Nonclinical | Toxicology | Carcinogenicity

Overseas effective date: 1 Aug 2014

ICH Guideline S10 on photosafety evaluation of pharmaceuticals

Replaces: CPMP/SWP/398/01 Note for Guidance on Photosafety Testing (Adopted by TGA 17 September 2004) and EMA/CHMP/SWP/336670/2010 Question and answers on the 'Note for guidance on photosafety testing' (provided for information 24 February 2014)

Categories: Nonclinical | Toxicology | Other toxicity

Overseas effective date: 1 Jun 2014

ICH guideline S6 (R1) - preclinical safety evaluation of biotechnology-derived pharmaceuticals

Replaces: CPMP/ICH/302/95. Note for Guidance on Preclinical Safety Evaluation of Biotechnology Derived Pharmaceutical (Adopted by TGA 1 October 1999)

Categories: Nonclinical | Pharmacology | Nonclinical | General (nonclinical)