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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 91 - 100 of 373

Overseas effective date: 10 Feb 2009

Guideline on Clinical Investigation of Medicinal Products for the Treatment of Migraine

Replaces: CPMP/EWP/788/01 (Adopted by TGA 19 April 2001)

Categories: Clinical efficacy and safety | Nervous system

Overseas effective date: 1 Dec 1998

ICH Topic S1A - Note for Guidance on The Need for Carcinogenicity Studies of Pharmaceuticals

Categories: Nonclinical | Toxicology | Carcinogenicity

Overseas effective date: 9 Feb 2006

ICH Topic E 14 - Note for Guidance on Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

Categories: Clinical efficacy and safety | Cardiovascular system | Arrythmias

QT prolongation would be of regulatory concern if either the estimated QT prolongation was >5ms OR the upper bound of the 95% confidence interval was >10ms

Overseas effective date: 25 May 2015

ICH guideline Q10 on pharmaceutical quality system

Categories: Quality | Pharmaceutical development (quality)

Overseas effective date: 12 Dec 2017

ICH guideline Q4B Annex 1 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on residue on ignition/sulphated ash (step 5)

Categories: Quality | Specifications and analytical procedures and analytical validation

Overseas effective date: 25 May 2015

ICH guideline Q9 on quality risk management

Categories: Quality | Pharmaceutical development (quality)

Overseas effective date: 1 Apr 2014

ICH guideline Q8, Q9 and Q10 - questions and answers volume 4

Replaces: May 2009 version (provided for information May 2010)

Categories: Quality | Specifications and analytical procedures and analytical validation

For information: 1 April 2014

Overseas effective date: 19 Apr 2001

ICH Topic E 11 - Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population

Categories: Clinical efficacy and safety | General (clinical)

Overseas effective date: 24 Aug 2004

ICH Topic Q 1 A (R2) - Note for Guidance on Stability Testing: Stability Testing of New Drug Substances and Products

Categories: Quality | Stability

Overseas effective date: 1 May 2000

ICH Topic Q 5 B - Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines Used for Production of r-DNA Derived Protein Products

Categories: Biological medicines | Drug substance | Manufacture and characterisation and control of the drug substance

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