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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 - 10 of 11

Overseas effective date: 16 Jun 2004

Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products

Replaces: CPMP/QWP/122/02 and CPMP/QWP/556/96

Categories: Quality | Stability

Overseas effective date: 24 Aug 2004

ICH Topic Q 1 A (R2) - Note for Guidance on Stability Testing: Stability Testing of New Drug Substances and Products

Categories: Quality | Stability

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 Oct 1999

ICH Topic Q 1 B - Photostability Testing of New Active Substances and Medicinal Products

Categories: Quality | Stability

Overseas effective date: 27 Mar 2002

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

Categories: Quality | Stability

Overseas effective date: 1 Oct 1999

ICH Topic Q 1 C - Note for Guidance on Stability Testing: Requirements for New Dosage Forms

Categories: Quality | Stability

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: 7 May 2003

ICH Topic Q 1 D - Note for Guidance on Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products

Categories: Quality | Stability

Overseas effective date: 24 Aug 2004

ICH Topic Q 1 E - Note for Guidance on Evaluation of Stability Data

Categories: Quality | Stability

Overseas effective date: 17 Sep 2004

ICH Topic Q 1 F - Note for Guidance on Stability Data Package for Registration in Climatic Zones III and IV

Categories: Quality | Stability

The TGA acknowledges this Guideline has been withdrawn by the ICH, as set out in Explanatory Note on the Withdrawal of ICH Q1F from the ICH Website (pdf,111kb).

This guideline remains adopted by the TGA because a significant portion of Australia lies in climatic zones III and IV. The guideline requires at least 12 months stability testing at 30°C/65% rh, 6 months testing at 40°C/75% rh, 3 months testing at 50°C (in certain circumstances) and 3 months testing at 25°C/80% rh (for solid dosage forms in water-vapour permeable packaging). However, the TGA allows some alternatives to these requirements, as follows:

  1. Testing at 50°C is not required.
  2. Testing at 25°C/80% rh is not required if the product shows satisfactory stability during long term testing at 30°C/65% rh.
  3. If a product does not show satisfactory stability for at least 3 months at 40°C/75% rh, there are several acceptable options:
    • argue that, as the container is designed to provide a barrier to water vapour, further investigation of stability under conditions of high humidity is not necessary; or
    • demonstrate, by testing at least 3 batches, that the product is stable for 3-6 months at 30°C/75% rh; or
    • package the product in a container/closure system that is less permeable to water vapour; or
    • label the product "Store below 25°C".
  4. If a product is labelled "Store below 25°C", the TGA will accept:
    • long term stability testing at 25°C/60% rh in place of 30°C/65% rh; and
    • 6 months testing at 25°C/80% rh or 30°C/65% rh (at least 3 batches) in place of 40°C/75% rh. Nevertheless, initial testing of the product should be conducted in accordance with the guideline, ie, at 30°C/65% rh and 40°C/75% rh. If stability is inadequate under these conditions (and, if tested, the alternative condition of 30°C/75% rh) the use of more protective packaging should be considered before the option of labelling the product "Store below 25°C".

Generally, if a product shows satisfactory stability for at least 3 months at a high humidity test condition (40°C/75% rh, 30°C/75% rh, 30°C/65% rh or 25°C/80% rh, as appropriate), then the TGA will consider a shelf life of up to 2 years, subject to satisfactory long term stability data. If a product is stable for 6 months under these conditions then a shelf life in excess of 2 years will be considered. [Any of these four storage conditions would be acceptable for high humidity testing of a product labelled "Store below 25°C", but only 40°C/75% rh or 30°C/75% rh would be acceptable for a product labelled "Store below 30°C".]

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