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International scientific guidelines adopted in Australia

5 August 2020

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
  • Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • Food and Drug Administration (USA)

International 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 guidelines that are adopted in Australia prior to manufacturing and supplying a medicine.

While guidelines that are adopted in Australia are generally not mandated by 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 any Guideline, the TGA undertakes an extensive process of internal and external consultations to ensure the Guideline is consistent with prevailing requirements in Australia. TGA publishes a searchable list of International 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.

International scientific guidelines adopted in Australia

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Overseas effective date: 17 Dec 2010

Addendum to the Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections To Specifically Address the Clinical Development of New Agents to Treat Disease due to Mycobacterium Tuberculosis

Replaces: EMEA/CHMP/EWP/122355/2007 (Adopted by TGA 10 February 2009)

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

The Report of the Joint Expert Advisory Committee on Antibiotic Resistance (1999) accepted by the Commonwealth, also includes recommendations for assessment of the propensity for promoting resistance and cross-resistance.

Overseas effective date: 25 May 2015

Guideline on similar biological medicinal products

Replaces: CHMP/437/04 (adopted by TGA 15 June 2006)

Categories: Biological medicines | Drug substance | Comparability/biosimilarity | Multidisciplinary | Biosimilars | Overarching

Overseas effective date: 25 Feb 2009

ICH Topic E15 - Note for Guidance on Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories

Categories: Multidisciplinary | Pharmacogenomics