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…