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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 121 - 130 of 373

Overseas effective date: 17 Jun 2015

Guideline on the quality of transdermal patches

Replaces: CPMP/QWP/604/96. Note for Guidance on Quality of Modified Release Products: [B: Transdermal Dosage Forms] (adopted by TGA April 2001)

Categories: Quality | Specific types of products

Overseas effective date: 1 Oct 2006

Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products

Categories: Quality | Specific types of products

Overseas effective date: 1 May 2000

Note for Guidance on Manufacture of the Finished Dosage Form

Categories: Quality | Manufacturing

Overseas effective date: 25 May 2015

Guideline on stability testing for applications for variations to a marketing authorisation

Categories: Quality | Stability

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

Overseas effective date: 31 Jan 2015

Guideline on quality of oral modified release products

Replaces: CPMP/QWP/604/96 Note for Guidance on Quality of Modified Release Products: [A: Oral Dosage Forms] (Adopted by TGA 19 April 2001)

Categories: Quality | Specific types of products

Overseas effective date: 28 May 2010

Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product

Replaces: 3AQ9a and CPMP/CVMP/QWP/115/95

Categories: Quality | Excipients

Overseas effective date: 22 Jun 2009

Guideline for Radiopharmaceuticals

Categories: Quality | Specific types of products

Overseas effective date: 4 Jan 2006

Guideline on summary of requirements for Active Substances in the quality part of the dossier

Replaces: CHMP/QWP/297/97 (Adopted by TGA 12 February 2003)

Categories: Quality | Active substance

The pharmacopoeias of EU member states, other than the British and European Pharmacopoeias (BP and Ph Eur), have no standing in Australia. The official standards in Australia are the British Pharmacopoeia (BP), the European Pharmacopoeia (Ph Eur) and the United States Pharmacopeia-National Formulary (USP).

Additional TGA requirements for active substances, Drug Master Files and Certificates of Suitability are set out in the Australian Regulatory Guidelines for Prescription Medicines.

Overseas effective date: 23 Oct 2008

Guideline on the Non-Clinical Development of Fixed Combinations of Medicinal Products

Categories: Nonclinical | General (nonclinical)

Overseas effective date: 25 May 2015

CHMP SWP Conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment

Categories: Nonclinical | Toxicology | Carcinogenicity

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