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International scientific guidelines adopted in Australia
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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
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
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)