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.
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.
This guidance does not extend to medicines other than complementary medicines nor is it applicable to other medicines containing a complementary medicine component.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.