The purpose of an evidence package is to demonstrate to the TGA that the medicine will produce the therapeutic effects described by its indications, as stated by the sponsor’s legal responsibilities.
Evidence can come from sources showing traditional use or scientific evidence. Traditional use requires at least 75 years of documented use within a specific medical paradigm. Scientific evidence refers to data from clinical trials, epidemiological studies, etc in humans.
A literature search identifies potential evidence sources. Both systematic and non-systematic searches can be done. The search methodology should be documented.
Each evidence source should be assessed for relevance to the medicine’s design and indications. Factors like active ingredients, dose, method of preparation, frequency/duration of use, and study population should match the medicine, unless justified.
The quality of evidence sources should also be assessed. Scientific evidence can be categorized into a hierarchy based on risk of bias. Study design, methods, statistical analysis, clinical significance etc. are important factors. Traditional evidence should come from credible sources establishing a tradition of use.
Indications can be traditional, scientific (further categorized as specific or non-specific), or a combination. Different evidence expectations apply for each indication type.
The evidence package should include a critical appraisal of the overall body of evidence explaining how it demonstrates the medicine’s efficacy. Justifications should be provided for discrepancies between the evidence sources and the medicine.
Overall, the evidence package should show the medicine will produce the effects described by its indications, meeting the sponsor’s legal requirements. The format is flexible but should clearly communicate the sponsor’s rationale.