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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 51 - 60 of 359

TGA adopted date: 26 Mar 2002

Points to consider on the calculation and reporting of the prevalence of a condition for orphan designation

Categories: Clinical efficacy and safety | General (clinical)

p>The TGA has published guidance on eligibility criteria and supporting documentation for orphan drug designation in accordance with Part 3B of the Therapeutic Goods Regulations 1990.

EU/ICH effective date: 13 Jan 2005

Guideline on the clinical investigation of Plasma derived Fibrin Sealant/Haemostatic Products

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

EU/ICH effective date: 1 Jun 2006

Guideline on the Clinical Investigation of Human Plasma Derived Von Willebrand Factor Products

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

EU/ICH effective date: 16 Oct 2003

Note for Guidance on the Clinical Investigation of Plasma Derived Antithrombin Products

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

If a sponsor believes that the patient numbers specified in this guideline are not achievable in Australia, advice should be sought from the TGA.

EU/ICH effective date: 10 Feb 2009

Guideline on the Clinical Investigation of Human Anti-D Immunoglobulin for Intravenous and/or Intramuscular Use

Replaces: CPMP/BPWG/575/99 (Adopted by TGA 19 April 2001)

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

EU/ICH effective date: 10 Jan 2002

Position Statement on the Use of Tumourigenic Cells of Human Origin for the Production of Biological and Biotechnological Medicinal products

Categories: Biological medicines | Drug substance | Manufacture and characterisation and control of the drug substance

EU/ICH effective date: 12 Feb 2002

Harmonisation of Requirements for Influenza Vaccines

Replaces: III/3188/91 (Adopted by TGA July 1994)

Categories: Biological medicines | Drug substance | Vaccines (drug substance) | Multidisciplinary | Vaccines (multidisciplinary)

Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.

The nonclinical and clinical aspects of this Guidelines continue to apply.

EU/ICH effective date: 5 Mar 2003

Cell Culture Inactivated Influenza Vaccines - Annex to Note for Guidance on Harmonisation of Requirements for Influenza Vaccines CPMP/BWP/214/96

Categories: Biological medicines | Drug substance | Vaccines (drug substance) | Multidisciplinary | Vaccines (multidisciplinary)

Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.

The nonclinical and clinical aspects of this Guidelines continue to apply.

EU/ICH effective date: 10 Jan 2002

Points to Consider on the Reduction, Elimination or Substitution of Thiomersal in Vaccines

Categories: Biological medicines | Drug substance | Vaccines (drug substance) | Multidisciplinary | Vaccines (multidisciplinary)

EU/ICH effective date: 1 Aug 1997

Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Virus

Categories: Biological medicines | Drug product | Adventitious agents safety evaluation viral safety

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