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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 61 - 70 of 346

EU/ICH effective date: 19 Apr 2001

Development Pharmaceutics for Biotechnological and Biological Products (Annex to Note for Guidance on Development Pharmaceutics)

Categories: Biological medicines | Drug product | Pharmaceutical development

EU/ICH effective date: 13 Feb 2001

Note for Guidance on Pharmaceutical and Biological Aspects of Combined Vaccines

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

EU/ICH effective date: 20 May 2005

Guideline on assessing the risk for virus transmission - New chapter 6 of the note for guidance on plasma - derived medicinal products (CPMP/BWP/269/95)

Categories: Biological medicines | Drug substance | Plasma-derived medicinal products

EU/ICH effective date: 12 May 2005

Guideline on the investigation of manufacturing processes for plasma-derived medicinal products with regard to VCJD risk

Categories: Biological medicines | Drug substance | Plasma-derived medicinal products | Biological medicines | Drug product | CJD related

EU/ICH effective date: 1 Apr 2014

Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus

Replaces: CPMP/EWP/1080/00 (Adopted by TGA 23 October 2002)

Categories: Clinical efficacy and safety | Alimentary tract and metabolism

EU/ICH effective date: 28 May 2010

Clinical Evaluation of Diagnostic Agents

Replaces: CPMP/EWP/1119/98

Categories: Clinical efficacy and safety | General (clinical) | Clinical efficacy and safety | Radiopharmaceuticals and diagnostic agents

EU/ICH effective date: 1 Aug 2014

Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Urinary Incontinence

Replaces: CPMP/EWP/18/01 (Adopted by TGA 4 February 2004)

Categories: Clinical efficacy and safety | Genito-urinary system and sex hormones

EU/ICH effective date: 7 Jun 2005

Points to Consider on the Clinical Requirements of Modified Release Products Submitted as a Line Extension of an Existing Marketing Authorisation

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

EU/ICH effective date: 19 Apr 2001

Points to Consider Concerning Endpoints in Clinical Studies with Haematopoeitic Growth Factors for Mobilisation of Autologous Stem Cells

Categories: Clinical efficacy and safety | Blood and blood-forming organs

EU/ICH effective date: 25 Feb 2009

Guideline on the Development of New Medicinal Products for the Treatment of Crohn's Disease

Replaces: CPMP/EWP/2284/99 (Adopted by TGA 10 January 2002)

Categories: Clinical efficacy and safety | Alimentary tract and metabolism

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