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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 - 8 of 8
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
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: 1 Aug 2019
Octreotide acetate depot powder and solvent for suspension for injection 10mg, 20mg or 30mg 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
Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1
Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics
Overseas effective date: 1 Aug 1997
Note for Guidance on the Clinical Requirements for Locally Applied, Locally Acting Products Containing Known Constituents
Replaces: CPMP/EWP/239/95
Categories: Clinical efficacy and safety | General (clinical)
Overseas effective date: 1 Jun 2015
Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1)
Replaces: CPMP/EWP/280/96 Corr. Note for Guidance on Modified Release Oral and Transdermal dosage forms: Section II (Pharmacokinetic and Clinical Evaluation) (corrected version adopted by TGA 1 June 2014)
Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics
Overseas effective date: 16 Jun 2011
Guideline on the Investigation of Bioequivalence
Replaces: CPMP/QWP/EWP/1401/98 (Adopted by TGA 12 February 2002)
Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Multidisciplinary | Miscellaneous