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: Guidance on the format of the risk management plan (RMP) in the EU - in integrated formatInternational scientific guidelines adopted in AustraliaEMA/164014/2018 Rev.2.0.1 adopted by the Therapeutic Goods Administration (TGA)
- International scientific guideline: Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic FunctionInternational scientific guidelines adopted in AustraliaCPMP/EWP/2339/02 adopted by the Therapeutic Goods Administration (TGA)
- International scientific guidelines adopted in AustraliaCHMP/437/04 Rev. 1 adopted by the Therapeutic Goods Administration (TGA)