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International scientific guidelines adopted in Australia
International scientific guidelines that are adopted in Australia provide guidance to sponsors to assist them to meet the legislative requirements.
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 over-the-counter (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.
The guidelines are generally not mandated by legislation, 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. 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.
Similarly, where FDA guidelines adopted in Australia include references to US legislation, the requirements contained in the referenced US legislation are not applicable to the evaluation of medicines by the TGA.
Recently updated International scientific guidelines adopted in Australia
- International scientific guideline: Guideline on process validation for finished products - information and data to be provided in regulatory submissionInternational scientific guidelines adopted in AustraliaEMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1 adopted by the Therapeutic Goods Administration (TGA)
- International scientific guideline: ICH Topic Q3B (R2) - Note for guidance on impurities in new drug productsInternational scientific guidelines adopted in AustraliaCPMP/ICH/2738/99 adopted by the Therapeutic Goods Administration (TGA)
- International scientific guideline: FDA: Submitting documents using RWD and RWE to FDA for drugs and biologics - Guidance for industryInternational scientific guidelines adopted in AustraliaSubmitting documents using real world data (RWD) and real world evidence (RWE) to FDA for drugs and biologics – Guidance for Industry adopted by the Goods Administration (TGA)