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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 71 - 80 of 373

Overseas effective date: 27 Mar 2002

Note for Guidance on In-Use Stability Testing of Human Medicinal Products

Categories: Quality | Stability

Overseas effective date: 25 May 2015

Guideline on Active Substance Master File Procedure

Replaces: CPMP/QWP/227/02 Rev 2 (adopted by TGA June 2013)

Categories: Quality | Active substance

EU-specific procedural requirements stated in this Guideline do not apply in Australia.

Overseas effective date: 1 Jun 2013

Guideline on setting specifications for related impurities in antibiotics

Categories: Quality | Impurities

Overseas effective date: 1 Dec 2014

Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations

Replaces: CPMP/QWP/3309/01, EMEA/CVMP/961/01. Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations. (Adopted by TGA 15 November 2004)

Categories: Quality | Specifications and analytical procedures and analytical validation

Overseas effective date: 26 Jun 2009

Guideline on Medicinal Gases: Pharmaceutical Documentation (Including Recommendation on Non-Clinical Safety Requirements for Well Established Medicinal Gases)

Replaces: CPMP/QWP/1719/00 (Adopted by TGA 12 March 2003)

Categories: Nonclinical | General (nonclinical) | Quality | Specific types of products

Overseas effective date: 23 Feb 2001

Note for Guidance on Maximum Shelf Life for Sterile Products After First Opening or Following Reconstitution (Annex to the Note for Guidance on Stability Testing of New Active substances and Medicinal Products (CPMP/ICH/380/95))

Categories: Quality | Stability

The allowance '.....unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions' detailed in the section: 'Unpreserved Sterile Products - Specific Text for Preparations for Infusion or Injection.' will only be permitted for products prepared in TGA licensed compounding facilities and in those hospital pharmacies that have been formally audited to the NCCTG standard and SHPA guidelines and have demonstrated that they can provide the appropriate level of sterility assurance.

Overseas effective date: 1 May 2000

Note for Guidance on Development Pharmaceutics

Categories: Quality | Pharmaceutical development (quality)

Overseas effective date: 7 Oct 2004

Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeia General Monograph "Substances for Pharmaceutical Use" and General Chapter "Control of Impurities in Substances for Pharmaceutical Use"

Categories: Quality | Impurities

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.

Overseas effective date: 12 Feb 2002

Guideline on the Chemistry of New Active Substances

Replaces: 3AQ5a (Adopted by TGA February 2002)

Categories: Quality | Active substance