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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 11 - 20 of 359

EU/ICH effective date: 12 Feb 2002

Pharmacokinetic Studies in Man

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

EU/ICH effective date: 1 Apr 2006

ICH Topic S 8 - Note for Guidance on Immunotoxicity Studies for Human Pharmaceuticals

Categories: Nonclinical | Toxicology | Other toxicity

EU/ICH effective date: 25 May 2015

Guideline on similar biological medicinal products

Replaces: CHMP/437/04 (adopted by TGA 15 June 2006)

Categories: Biological medicines | Drug substance | Comparability/biosimilarity | Multidisciplinary | Biosimilars | Overarching

EU/ICH effective date: 1 Sep 2015

Clinical investigation of medicinal products for the treatment of systemic lupus erythematosus, cutaneous lupus and lupus nephritis

Categories: Clinical efficacy and safety | Rheumatology / musculoskeletal system

In place of: EMEA/CHMP/EWP/604040/2009 Concept Paper on the Need for a Guideline on the Clinical Investigation of Medicinal Products Intended for Treatment of Systematic and Cutaneous Lupus Erythematosus (provided for information 26 March 2010)

EU/ICH effective date: 1 Oct 2015

Clinical investigation of medicinal products for the treatment of multiple sclerosis

Replaces: CPMP/EWP/561/98 Rev. 1 Guideline on clinical investigation of Medicinal Products for the Treatment of Multiple Sclerosis (Adopted by TGA 8 April 2009)

Categories: Clinical efficacy and safety | Nervous system

EU/ICH effective date: 2 Feb 2016

Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg)

Replaces: EMEA/CPMP/BPWG/283/00 Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular Use (Adopted by TGA 12 March 2003)

Categories: Clinical efficacy and safety | Blood products (including biotech alternatives)

EU/ICH effective date: 2 Feb 2016

Guideline on the clinical investigation of hepatitis B immunoglobulins

Categories: Clinical efficacy and safety | Blood products (including biotech alternatives)

EU/ICH effective date: 1 Apr 2014

Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease

Replaces: CPMP/EWP/1343/01 (Adopted by TGA 17 September 2008)

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

EU/ICH effective date: 8 Apr 2009

Guideline on the Development of New Medicinal Products for the Treatment of Ulcerative Colitis

Categories: Clinical efficacy and safety | Alimentary tract and metabolism

EU/ICH effective date: 15 Jul 2009

Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases

Categories: Clinical efficacy and safety | Allergy/Immunology

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