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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 21 - 30 of 373
TGA adopted date: 28 Feb 2020
Overseas effective date: 1 Jul 2016
Clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy
Categories: Clinical efficacy and safety | Nervous system
TGA adopted date: 15 Jul 2019
Overseas effective date: 15 Jul 2019
Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU
Categories: Multidisciplinary | Vaccines (multidisciplinary)
TGA adopted date: 15 Jul 2019
Overseas effective date: 31 Oct 2019
Guidance on the format of the risk management plan (RMP) in the EU - in integrated format
Categories: Pharmacovigilance
TGA adopted date: 15 Jul 2019
Overseas effective date: 29 Mar 2019
ICH Q 3 D Impurities: guideline on elemental impurities
Categories: Quality | Impurities
TGA adopted date: 15 Jul 2019
Overseas effective date: 13 Oct 2019
Guideline on good pharmacovigilance practices (GVP) Module XV - Safety communication (Rev 1)
Categories: Pharmacovigilance
TGA adopted date: 15 Jul 2019
Overseas effective date: 15 Jul 2019
Ezetimibe tablet 10mg product - specific bioequivalence guidance
Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence
TGA adopted date: 15 Jul 2019
Overseas effective date: 6 Jun 2019
Guideline on the content, management and archiving of the clinical master file (paper and/or electronic)
Categories:
TGA adopted date: 15 Jul 2019
Overseas effective date: 15 Jul 2019
Apixaban film-coated tablet 2.5 and 5mg product -specific bioequivalence guidance
Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence
TGA adopted date: 15 Jul 2019
Overseas effective date: 15 Jul 2019
Aliskiren film-coated tablet 150mg and 300mg product specific bioequivalence guidance
Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence
TGA adopted date: 15 Jul 2019
Overseas effective date: 15 Jul 2019
Gefitinib film-coatred tablet 250mg product-specific bioeqivalence guidance
Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence