Appendix IV of the Guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1

About this guideline

Overseas effective date: 1 June 2012

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics

TGA annotations

1. 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.
2. 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.
3. Table 3.1 should be amended according to the metrics that are suitable for the product and/or study type.

For more information see International scientific guidelines adopted in Australia.