We do not require biopharmaceutic data or a justification for not providing this data for:
Peritoneal dialysis solutions.
Simple aqueous solutions for intravenous injection or infusion (simple solutions do not include complex solutions such as emulsions, micellar or liposomal solutions).
Other parenteral routes, e.g. intramuscular or subcutaneous, provided that the test product is of the same type of solution (aqueous or oily) and contains the same concentration of the same active substance and the same excipients in similar amounts as the reference product.
Simple solutions that do not contain a pharmacologically active drug substance e.g., sodium chloride injection.
Oral solutions that both:
contain the same drug substance(s) in the same concentration as a currently registered oral solution
do not contain excipients that may significantly affect: gastric passage or absorption of the drug substance(s) in vivo solubility or in vivo stability of the drug substance.
Medicines containing drug substances that are not systemically or locally absorbed. Examples include:
barium sulfate enemas
nonbiodegradable ion exchange resins
other nonbiodegradable long-chain polymers
powders from which no ingredient is absorbed.
Note: A study or justification may be required if there is doubt asto whether absorption occurs.
Medicines applied locally (e.g. inhalation and nasal medicines, ocular, dermal, rectal, or vaginal administration) except where the drug substance is acting systemically.
Note: Inhaled steroid products should be supported by data on systemic exposure as part of the evidence of their safety, even in cases where they are intended to act locally.
Medicines with an acceptable correlation between the rate and extent of in vivo absorption and the in vitro dissolution rate, and where the in vitro dissolution rate of the new medicine is equivalent (under the same test conditions used to establish the correlation) to a registered medicine.
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.