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Scientific guidelines

EU guidelines

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 and Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. EU and ICH 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 EU and ICH guidelines that are adopted in Australia prior to manufacturing and supplying a medicine.

While EU and ICH Guidelines adopted in Australia are generally not mandated in Australian 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 an EU or ICH Guideline, the TGA undertakes an extensive process of internal and external consultations to ensure the Guidelines in consistent with prevailing requirements in Australia. TGA publishes a searchable list of European Union and ICG 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.

European Union and ICH Guidelines adopted in Australia

Displaying 31 - 40 of 346

EU/ICH effective date: 5 Feb 2008

Guideline on Clinical Investigation of Medicinal Products for the Treatment of Psoriatic Arthritis

Categories: Clinical efficacy and safety | Rheumatology / musculoskeletal system

EU/ICH effective date: 29 Sep 2006

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

Categories: Clinical efficacy and safety | Anti-infectives for systemic use

EU/ICH effective date: 17 Dec 2010

Guideline on Clinical Investigation of Medicinal Products in the Treatment of Epileptic Disorders

Replaces: CPMP/EWP/566/98 Rev 1 (Adopted by TGA 19 April 2001)

Categories: Clinical efficacy and safety | Nervous system

EU/ICH effective date: 1 Sep 2006

Guideline on the Clinical Evaluation of Medicinal Products intended for Treatment of Hepatitis B

Categories: Clinical efficacy and safety | Anti-infectives for systemic use

EU/ICH effective date: 1 Dec 2006

Guideline on Clinical Trials in Small Populations

Categories: Clinical efficacy and safety | Biostatistics

EU/ICH effective date: 6 Jan 2009

Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins

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

EU/ICH 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

EU/ICH effective date: 25 Jul 2016

ICH Q 3 D Impurities: guideline on elemental impurities

Replaces: ICH guideline Q3D

Categories: Quality | Impurities

EU/ICH effective date: 10 Nov 2014

ICH guideline Q4B annex 13 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bulk density and tapped density of powders - general chapter

Categories: Quality | Specifications and analytical procedures and analytical validation

EU/ICH effective date: 10 Nov 2014

ICH guideline Q4B - Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests - general chapter

Categories: Quality | Specifications and analytical procedures and analytical validation

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