You are here

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 71 - 80 of 346

EU/ICH effective date: 27 Mar 2002

Points to Consider on Application with 1. Meta-Analyses; 2. One Pivotal Study

Categories: Clinical efficacy and safety | Biostatistics

Sponsors are reminded that they should submit all available new safety data that are relevant to the intended treatment population.

EU/ICH effective date: 4 Jan 2006

Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function

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

EU/ICH effective date: 29 Sep 2006

Guideline on The Clinical Investigation of Anti-Anginal Medicinal Products in Stable Angina Pectoris

Replaces: 3CC20a (Adopted by TGA 12 February 2002)

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

EU/ICH effective date: 23 Feb 2001

Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Cardiac Failure

Categories: Clinical efficacy and safety | Cardiovascular system | Heart failure

EU/ICH effective date: 1 Aug 1997

Note for guidance on antiarrhythmics

Categories: Clinical efficacy and safety | Cardiovascular system | Arrythmias

EU/ICH effective date: 1 Aug 1997

Note for Guidance on the Clinical Requirements for Locally Applied, Locally Acting Products Containing Known Constituents

Replaces: CPMP/EWP/239/95

Categories: Clinical efficacy and safety | General (clinical)

The following explanatory note was added on 28 October 2011:

The TGA does not consider this guideline to be applicable to applications seeking the registration of eye drops that exert their effect beyond the cornea (i.e. the deeper tissues of the eye). Examples of such eye drops include eye drops for the treatment of glaucoma.

Requirements for establishing the bioequivalence of such eye drops to an innovator product are set out in the EU guideline Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1) that has been adopted.

EU/ICH effective date: 14 Apr 2009

Guideline on Clinical Medicinal Products Intended for the Treatment of Neuropathic Pain

Replaces: CHMP/EWP/252/03 (Adopted by TGA 1 June 2005)

Categories: Clinical efficacy and safety | Nervous system

EU/ICH effective date: 19 Apr 2001

Points to Consider on Pharmacokinetics and Pharmacodynamics in the Development of Antibacterial Medicinal Products

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

EU/ICH effective date: 12 Mar 2003

Note for Guidance on Coordinating Investigator Signature of Clinical Study Reports

Categories: Clinical efficacy and safety | General (clinical)

EU/ICH effective date: 2 Feb 2016

Guideline on clinical investigation of medicinal products for the treatment of acute heart failure

Replaces: CPMP/EWP/2986/03 Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Cardiac Failure. Addendum on Acute Cardiac Failure (CPMP/EWP/235/95 Rev 1); and EMA/CHMP/EWP/215701/2010 Concept paper on the need for revision of the addendum on acute cardiac failure (CPMP/EWP/2986/03) (provided for information 1 August 2014)

Categories: Clinical efficacy and safety | Cardiovascular system | Heart failure

Pages