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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 1 - 3 of 3

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)

The following explanatory note was added on 28 October 2011:

The TGA does not consider this guideline to be applicable to applications seeking the registration of eye drops that exert their effect beyond the cornea (i.e. the deeper tissues of the eye). Examples of such eye drops include eye drops for the treatment of glaucoma.

Requirements for establishing the bioequivalence of such eye drops to an innovator product are set out in the EU guideline Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1) that has been adopted.

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

  1. The procedure for abridged applications claiming essential similarity to a reference product (i.e., for generic medicines), which allows applications to be made to numerous Member States of the EU, based on bioequivalence with a reference product from one Member State, does not apply in Australia. Unless otherwise justified, an application for registration of a generic medicine in Australia should generally include one or more bioequivalence studies, each versus the Australian reference product. Directions given in this guideline regarding "non-EU reference products" (Section 2), and "Member State where the reference product is purchased from" (Table 2.1) should be disregarded in favour of the advice given in TGA Guidance 15: Biopharmaceutic studies.
  2. Similarly, details of the (presumably most recent) EU Authority Inspection of the clinical and bioanalytical study sites and site of the PK and statistical analysis (Table 2.2) are GCP/GLP issues, and need not be provided.
  3. Table 3.1 should be amended according to the metrics that are suitable for the product and/or study type.

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

While this guidance suggests that the design and conduct of the study should follow EU regulations on Good Clinical Practice, sponsors should note that the EU Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) has been adopted in Australia with TGA annotations.

The procedure for abridged applications claiming essential similarity to a reference product (i.e., generics), which allows applications to be made to numerous Member States of the EU, based on bioequivalence with a reference product from one Member State, does not apply in Australia. An application for registration of a generic product in Australia should generally include a bioequivalence study versus a leading brand obtained in Australia.