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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 81 - 90 of 346

EU/ICH effective date: 23 Feb 2010

Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence Between Two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for Use in the Treatment of Asthma in Children and Adolescents

Replaces: CPMP/EWP/4151/00 (Adopted by TGA January 2005)

Categories: Clinical efficacy and safety | Respiratory system

EU/ICH effective date: 1 Jul 2005

Guideline on the Clinical Investigation of Medicinal Products Indicated for Generalised Anxiety 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: 29 Jun 2001

Points to Consider on Switching between Superiority and Non-inferiority

Categories: Clinical efficacy and safety | Biostatistics

Please note that there is no requirement in Australia to demonstrate superiority.

EU/ICH effective date: 23 Feb 2010

Guideline on Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis

Categories: Clinical efficacy and safety | Rheumatology / musculoskeletal system

EU/ICH effective date: 17 Sep 2004

Appendix to the Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Schizophrenia (CPMP/EWP/559/95) - Methodology of Clinical Trials Concerning the Development of Depot Preparations of Approved Medicinal Products in Schizophrenia

Categories: Clinical efficacy and safety | Nervous system

EU/ICH effective date: 16 Mar 2009

Guideline on Non-Clinical and Clinical Development of Medical Products for the Prevention of Nausea and Vomiting Associated with Cancer Chemotherapy

Categories: Clinical efficacy and safety | Alimentary tract and metabolism

EU/ICH effective date: 7 Aug 2008

Guideline on the Evaluation of Medicinal Products in the Treatment of Primary Osteoporosis

Categories: Clinical efficacy and safety | Rheumatology / musculoskeletal system

EU/ICH effective date: 25 Feb 2009

Guideline on Medicinal Products for the Treatment of Alzheimer's Disease and Other Dementias

Replaces: CPMP/EWP/553/95 (Adopted by TGA 1 May 2000)

Categories: Clinical efficacy and safety | Nervous system

EU/ICH effective date: 29 Jan 2007

Points to Consider on Clinical Investigation of Medicinal Products other than NSAIDS for Treatment of Rheumatoid Arthritis

Replaces: CPMP/EWP/556/95 (Adopted by TGA February 2001)

Categories: Clinical efficacy and safety | Rheumatology / musculoskeletal system

EU/ICH effective date: 1 Apr 2014

Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

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

The Report of the Joint Expert Advisory Committee on Antibiotic Resistance (1999) accepted by the Commonwealth, also includes recommendations for assessment of the propensity for promoting resistance and cross-resistance.

In place of: EMEA/CHMP/EWP/435635/2008 concept paper on this topic (provided for information 1 May 2009)

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