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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 341 - 346 of 346

EU/ICH effective date: 1 Jan 2006

Guideline on Clinical Investigation of Steroid Contraceptives in Women

Replaces: EMEA/CPMP/EWP/519/98 (Adopted by TGA 19 April 2001)

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

EU/ICH effective date: 6 Jan 2017

Guideline on the clinical development of medicinal products for the treatment of HIV infection

Replaces: EMEA/CPMP/EWP/633/02 Revision 2 Guideline on the Clinical Development of Medicinal Products for the Treatment of HIV Infection (Adopted by TGA 15 July 2009)

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

EU/ICH effective date: 1 Apr 2014

Guideline on Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application (Revision)

Replaces: CPMP/VEG/4717/03 (Adopted by TGA 16 August 2004)

Categories: Biological medicines | Drug substance | Multidisciplinary | Vaccines (multidisciplinary) | Nonclinical | General (nonclinical)

Section 1.1.2. Pandemic variation

If the pandemic influenza virus is of a HN subtype for which nonclinical and clinical data have not been included in the Core Pandemic Dossier, it is highly desirable that nonclinical and clinical data obtained from studies with the pandemic HN subtype be included in the pandemic variation dossier.

Section 3.1.1

Candidate influenza vaccine virus should be taken to include the most recently available candidates and technologies, as noted on WHO website.

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: 9 Nov 2016

ICH GCP E6 (R2) - Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) - Annotated with TGA comments

Replaces: Note for guidance on good clinical practice (CPMP/ICH/135/95)

Categories: Clinical efficacy and safety | General (clinical)

Categories: Quality | Q and A on quality

Answers amended after 1 August 2014 are excluded until such time as they have been considered by TGA.

For information: 1 August 2014

EU/ICH effective date: 12 Feb 2002

Clinical Investigation of Medicinal Products for Long-Term Use

Replaces: pp. 163 - 165 of Rules 1989

Categories: Clinical efficacy and safety | General (clinical)