THE Therapeutic Goods
Administration has adopted a new
European Guideline on the
Investigation of Bioequivalence..
The TGA has added a note that
the EU procedure for abridged
applications claiming essential
similarity to a reference product
within the EU doesn’t apply here.
“An application for registration of
a generic product in Australia
should generally include a
bioequivalence study versus a
leading brand obtained in
Australia,” the note states.The above article was sent to subscribers in Pharmacy Daily's issue from 17 Jun 11 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 17 Jun 11