Prescription medicines collection

Guidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.

Guidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.

Guidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).

Guidance for sponsors about how to apply for orphan drug designation for a prescription medicine.

Guidance on submitting the CPD for prescription medicines.

Guidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93.

Guidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.

Guidance on applying for a provisional determination, which is the first step of the provisional approval pathway.

Guidance on how to request early scientific advice on a biowaiver justification.

Guidance on how we make use of assessments from comparable overseas regulators (CORs).