We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
Appendix IV of the Guideline on the investigation on bioequivalence
[PDF, 138.26 KB]
About this guideline
Overseas effective date: 1 June 2012
Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics
TGA annotations
- The procedure for abridged applications claiming essential similarity to a reference product (i.e., for generic medicines), which allows applications to be made to numerous Member States of the EU, based on bioequivalence with a reference product from one Member State, does not apply in Australia. Unless otherwise justified, an application for registration of a generic medicine in Australia should generally include one or more bioequivalence studies, each versus the Australian reference product. Directions given in this guideline regarding "non-EU reference products" (Section 2), and "Member State where the reference product is purchased from" (Table 2.1) should be disregarded in favour of the advice given in TGA Biopharmaceutic studies.
- Similarly, details of the (presumably most recent) EU Authority Inspection of the clinical and bioanalytical study sites and site of the PK and statistical analysis (Table 2.2) are GCP/GLP issues, and need not be provided.
- Table 3.1 should be amended according to the metrics that are suitable for the product and/or study type.
- Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
- All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.
For more information see International scientific guidelines adopted in Australia.