EVIDENCE MATTERS: for new and established medicines


All medicines provide benefits to patients whether it is to alleviate, treat or cure a condition, disease or disorder.

All medicines whether prescription medicines, over-the-counter medicines, vitamins, minerals and herbal complementary medicines are regulated by the Therapeutic Goods Administration (TGA) on a ‘risk-based’ model. The level of risk, as well as the history of its use, will determine the level of evidence required for the evaluation of the medicine by the TGA before it can be approved for supply to patients.

Information on the efficacy and safety of medicines are presented in a Common Technical Dossier (CTD) structure which consist of clinical, nonclinical (animal), quality, summaries and administrative information (e.g. product information and labelling).

New chemical and biological prescription medicines requires extensive animal/non-clinical (e.g. pharmacology and toxicology data) and clinical trial studies to demonstrate the safety and efficacy of the medicines, as well as quality data showing the composition of the drug substance and the drug product, batch consistency, stability data, sterility data (if applicable) and impurity content.

For generic medicines where the safety and efficacy of the medicine have been established, the evidence requirements will focus primarily on quality information and demonstrating bioequivalence with the reference product already registered in Australia.

The evidence requirements for a biosimilar medicine before it can be registered in Australia includes a number of laboratory and clinical studies to demonstrate the comparability (biosimilarity) of the new biosimilar to the reference biological medicine already registered in Australia.

For lower risk medicines (such as over-the-counter medicines), the evidence requirements consist of data to support the safety, quality and efficacy of the product as supported by literature and/or compliance with established monographs and or equivalence with the reference over-the-counter product already registered in Australia.

For complementary medicines (such as vitamins, minerals, herbal medicines), the active ingredient(s), formulation and dose need to be supported by literature evidence for the proposed permitted low level claims.

Regardless of the type of medicine, it must be demonstrated to be safe, efficacious and consistently manufactured and controlled, as supported by relevant evidence. Generating and having the right evidence will ultimately have a huge impact on the success of your medicine registration application.

We offer deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)


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