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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 21 - 30 of 346

EU/ICH effective date: 17 Dec 2010

Questions and Answers Document on the Clinical Development of Fixed Combinations of Drugs Belonging to Different Therapeutic Classes in the Field of Cardiovascular Treatment and Prevention

Categories: Clinical efficacy and safety | Cardiovascular system | Coronary artery disease (CAD)

EU/ICH effective date: 28 Jul 2005

Guideline on clinical investigation of medicinal products indicated for the treatment of Psoriasis

Categories: Clinical efficacy and safety | Dermatologicals

Section 5.2.5 on this guideline suggests that regulatory approval requires a comparison with an active comparator (e.g. cyclosporin, methotrexate etc). Placebo-controlled studies may also be acceptable in Australia.

EU/ICH effective date: 28 Jul 2005

Guideline on the clinical development of medicinal products for the treatment of allergic rhino-conjunctivitis

Categories: Clinical efficacy and safety | Allergy/Immunology

EU/ICH effective date: 8 Apr 2009

Guideline on Clinical Investigation of Immunosuppressants for Solid Organ Transplantation

Categories: Clinical efficacy and safety | Allergy/Immunology

EU/ICH effective date: 10 Nov 2016

Guideline on the clinical investigation of medicinal products for the treatment of asthma

Replaces: CPMP/EWP/2922/01 Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Asthma (adopted by TGA 7 January 2009)

Categories: Clinical efficacy and safety | Respiratory system

EU/ICH effective date: 23 Feb 2010

Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)

Replaces: CHMP/EWP/358650/2006 (Adopted by TGA 8 April 2009)

Categories: Clinical efficacy and safety | Nervous system

EU/ICH effective date: 1 Aug 2006

Guideline on Clinical Investigation of Medicinal Products Indicated for the Treatment of Social Anxiety Disorder (SAD)

Categories: Clinical efficacy and safety | Nervous system

EU/ICH effective date: 5 Aug 2009

Guideline on the Development of Medicinal Products for the Treatment of Smoking

Categories: Clinical efficacy and safety | Nervous system

EU/ICH effective date: 1 Jul 2005

Guideline on Clinical Investigation of Medicinal Products for the Treatment of Obsessive Compulsive Disorder

Replaces: pp. 371 - 380 of Rules 1998 (3C) - 3CC28a (Adopted by TGA 12 February 2002)

Categories: Clinical efficacy and safety | Nervous system

EU/ICH effective date: 1 Jul 2005

Guideline on the Clinical Investigation of Medicinal Products Indicated for the Treatment of Panic Disorder

Replaces: pp. 371 - 380 of Rules 1998 (3C) - 3CC28a (Adopted by TGA 12 February 2002)

Categories: Clinical efficacy and safety | Nervous system

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