We require biopharmaceutic data (unless otherwise justified) for new medicines that are:
- oral tablets
- oral capsules
- oral suspensions
- complex intravenous solutions for injection
- applied locally (e.g., inhalation and nasal medicines, ocular, dermal, rectal or vaginal administration) where the drug substance is acting systemically
- transdermal medicines.
For a new chemical entity
Absolute bioavailability study (compared with an intravenous injection or infusion). In the absence of an absolute bioavailability study, a relative bioavailability (compared with an oral solution or suspension of defined particle size).
Bioavailability studies to determine the relative bioavailabilities of the individual enantiomers in racemic drug substances.
Bioequivalence of the to-be- marketed formulation(s) compared with the formulation(s) used in pivotal dose-defining and efficacy studies.
Bioequivalence among the different strengths of the medicine proposed for registration.
Bioavailability studies to show the effect of food.
For a new salt
Biopharmaceutic data for the active moiety in the new salt compared with the currently registered salt.
For a new fixed combination medicine
Bioequivalence of the drug substance in the fixed combination medicine to each of the registered medicines containing the single entity.
Additional studies as required by the Guideline on clinical development of fixed combination medicinal products (EMA/CHMP/158268/2017).
For a new dosage form
Bioequivalence of the new dosage form to the currently registered dosage form(s).
For a new strength
Bioequivalence of the new strength(s) to the currently registered strength(s) of the innovator medicine if the biowaiver criteria are not met according to either:
- For immediate release dosage forms - Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **)
- For modified release dosage forms - Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CHMP/EWP/280/96).
For a new generic medicine
Bioequivalence of the new generic medicine to the corresponding innovator medicine marketed in Australia.
If the innovator medicine is no longer marketed in Australia, please email firstname.lastname@example.org for advice regarding the appropriate reference product against which the bioequivalence study should be conducted.
For a new formulation that may affect bioavailability
For innovator medicines, bioequivalence of the new formulation to the original formulation, unless justified in line with Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 1: Variation types - chemical entities.
For other medicines, bioequivalence of the new formulation to the corresponding innovator medicine, unless justified in line with Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 1: Variation types - chemical entities.
For a new modified-release formulation
The appropriate study(ies) in line with the following TGA adopted EMA guidelines:
- Guideline on quality of oral modified release products (EMA/CHMP/QWP/428693/2013).
- Guideline on the quality of transdermal patches (EMA/CHMP/QWP/608924/2014).
- Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CHMP/EWP/280/96) as amended.