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International scientific guidelines adopted in Australia

8 April 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 1 - 10 of 373

TGA adopted date: 28 Feb 2020

Clinical investigation of medicinal products for treatment of rheumatoid arthritis

Replaces: CPMP/EWP/556/95 rev 1/Final - Points to Consider on Clinical Investigation of Medicinal Products other than NSAIDS for Treatment of Rheumatoid Arthritis

Categories: Clinical efficacy and safety | Rheumatology / musculoskeletal system

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Jun 2000

ICH E12 Principles for clinical evaluation of new antihypertensive drugs

Categories: Clinical efficacy and safety | Cardiovascular system

This ICH document describes core principles for the evaluation of antihypertensive. It should be considered an 'ICH principle document' rather than an 'ICH guideline'. The reader should also refer to the most recent TGA adopted guidelines on the treatment of hypertension.

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Apr 2017

Guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency

Categories: Clinical efficacy and safety

Indigenous Australians experience a high rate of renal disease. Ideally, these should be included in clinical trials or a clinical trial in this group should be considered in the post market setting.

Many different terms are used to describe renal impairment, renal injury, renal failure. These terms should be clearly defined.

Where biomarkers are used - e.g. creatinine, urine albumin excretion, cystatin C - the value of these measures in the prediction of development of renal impairment should be included.

Outcomes should include need for renal replacement therapy or transplant.

Different centres may have different protocols for the management of CRF, thus clinical studies should include a protocol shared between sites, or results adjusted for potential differences in study centres.

TGA adopted date: 28 Feb 2020

Overseas effective date: 16 Nov 2018

ICH S9 Q&As Nonclinical Evaluation for Anticancer Pharmaceuticals - Questions and Answers

Categories: Clinical efficacy and safety | Antineoplastic and immunomodulating agents

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 May 2019

Treatment and prophylaxis of respiratory syncytial virus (RSV) disease

Categories: Multidisciplinary | Vaccines (multidisciplinary)

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Mar 2003

Scientific data requirements for a vaccine antigen master file

Categories: Multidisciplinary | Vaccines (multidisciplinary)

TGA adopted date: 28 Feb 2020

Overseas effective date: 10 Aug 2008

Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines

Categories: Multidisciplinary | Vaccines (multidisciplinary)

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Feb 2018

Quality aspects included in the product information for vaccines for human use

Categories: Multidisciplinary | Vaccines (multidisciplinary)

TGA adopted date: 28 Feb 2020

Overseas effective date: 2 Jul 2015

Influenza vaccines - submission and procedural requirements

Categories: Multidisciplinary | Vaccines (multidisciplinary)

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Jul 2002

Development of vaccinia virus-based vaccines against smallpox

Categories: Multidisciplinary | Vaccines (multidisciplinary)

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