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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

Displaying 101 - 110 of 373

Overseas effective date: 1 May 2000

3AB5a; ICH Q 5 C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

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

Overseas effective date: 1 Dec 2006

Guideline on Clinical Trials in Small Populations

Categories: Clinical efficacy and safety | Biostatistics

Overseas effective date: 15 Dec 2000

Points To Consider on Wording of Helicobacter Pylori Eradication Therapy in Selected SPC Sections

Categories: Clinical efficacy and safety | Alimentary tract and metabolism

Overseas effective date: 6 Jan 2009

Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins

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

Overseas effective date: 23 Jun 2005

Points to Consider on Multiplicity Issues in Clinical Trials

Categories: Clinical efficacy and safety | Biostatistics

Overseas effective date: 17 Dec 2010

Guideline on the Clinical Development of Medicinal Products for the Treatment of Cystic Fibrosis

Categories: Clinical efficacy and safety | Respiratory system

Overseas effective date: 8 Apr 2009

Guideline on the Non-Clinical Studies required before First Clinical Use of Gene Therapy Medicinal Products

Categories: Nonclinical | General (nonclinical) | Multidisciplinary | Biosimilars | Gene therapy

Overseas 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)

Overseas effective date: 1 May 2000

ICH Topic E 3 - Note for Guidance on Structure and Content of Clinical Study Reports

Categories: Clinical efficacy and safety | General (clinical)

Overseas effective date: 7 Oct 2008

Guideline On Clinical Investigation of Medicinal Products in the Treatment of Patients with Acute Respiratory Distress Syndrome

Categories: Clinical efficacy and safety | Respiratory system

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