Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
These guidance documents describe the minimum approach considered to be acceptable to achieve validation of the test procedures used for complementary medicines (products) and starting materials for use in complementary medicines. Each document also contains details of mandatory validation requirements, a glossary of terms, references and a flow chart to assist in determining the need for validation.
Guidance development
Draft documents were prepared by the Office of Complementary Medicines (OCM) / Industry Consultation Group (OICG) with input from other areas of the TGA. The draft documents were then circulated to the industry associations requesting comment on behalf of their members.
The OICG reviewed the comments received from industry and amended the documents to reflect agreed changes.
Scope
This guidance does not extend to medicines other than complementary medicines nor is it applicable to other medicines containing a complementary medicine component.