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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 41 - 50 of 346

EU/ICH effective date: 10 Nov 2014

ICH guideline Q4B annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on uniformity of dosage units - general chapter

Categories: Quality | Specifications and analytical procedures and analytical validation

EU/ICH effective date: 10 Nov 2014

ICH guideline Q4B annex 11 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on capillary electrophoresis - general chapter

Categories: Quality | Specifications and analytical procedures and analytical validation

EU/ICH effective date: 10 Nov 2014

ICH guideline Q4B annex 12 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on analytical sieving - general chapter

Categories: Quality | Specifications and analytical procedures and analytical validation

EU/ICH effective date: 1 Aug 2014

ICH Guideline S10 on photosafety evaluation of pharmaceuticals

Replaces: CPMP/SWP/398/01 Note for Guidance on Photosafety Testing (Adopted by TGA 17 September 2004) and EMA/CHMP/SWP/336670/2010 Question and answers on the 'Note for guidance on photosafety testing' (provided for information 24 February 2014)

Categories: Nonclinical | Toxicology | Other toxicity

EU/ICH effective date: 25 May 2015

Guideline on Active Substance Master File Procedure

Replaces: CPMP/QWP/227/02 Rev 2 (adopted by TGA June 2013)

Categories: Quality | Active substance

EU-specific procedural requirements stated in this Guideline do not apply in Australia.

EU/ICH effective date: 4 Jan 2006

Guideline on summary of requirements for Active Substances in the quality part of the dossier

Replaces: CHMP/QWP/297/97 (Adopted by TGA 12 February 2003)

Categories: Quality | Active substance

The pharmacopoeias of EU member states, other than the British and European Pharmacopoeias (BP and Ph Eur), have no standing in Australia. The official standards in Australia are the British Pharmacopoeia (BP), the European Pharmacopoeia (Ph Eur) and the United States Pharmacopeia-National Formulary (USP).

Additional TGA requirements for active substances, Drug Master Files and Certificates of Suitability are set out in the Australian Regulatory Guidelines for Prescription Medicines.

EU/ICH effective date: 1 May 2016

Guideline on non-clinical local tolerance testing of medicinal products

Replaces: To replace: CPMP/SWP/2145/00 Note for Guidance on Non-Clinical Local Tolerance Testing of Medicinal Products

Categories: Nonclinical | Toxicology | Local tolerance

EU/ICH effective date: 23 Oct 2008

Guideline on Influenza Vaccines Prepared from Viruses with the Potential to cause a Pandemic and Intended for Use Outside of the Core Dossier Context

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.

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)

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