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 prescription medicines in Australia are closely aligned with requirements set out in relevant European Union (EU) Guidelines and Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Prior to adopting an EU or ICH Guideline, the TGA undertakes an extensive process of internal and external consultation to ensure the Guideline is consistent with prevailing requirements in Australia. TGA publishes a List of European Union and ICH Guidelines adopted in Australia.
The Australian legislative requirements applying to prescription medicines are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, as well as in various legislative instruments such as Therapeutic Goods Orders, Notices and Determinations, see Legislation & legislative instruments.
While EU and ICH technical Guidelines adopted in Australia are generally not mandated in Australian 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.
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 prescription medicines by the TGA.
- Quality guidelines
- Biological medicines guidelines
- Nonclinical guidelines
- Clinical efficacy and safety guidelines
- Multidisciplinary guidelines
- Pharmacovigilance guidelines
For information on European Union guidelines replaced or superseded (previously published as adopted in Australia) please contact firstname.lastname@example.org