Proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Bioequivalence of medicines

Overview

This consultation is aimed at pharmaceutical companies seeking to demonstrate bioequivalence of medicines to support applications to Medsafe for regulatory approval of new and changed products. Prescribers and healthcare professionals with an interest in medicine regulation, in particular generic medicine approval, may also wish to participate. 

Medsafe is seeking your feedback on changes to the Guideline on the Regulation of Therapeutic Products in New Zealand: Part 6: Bioequivalence of medicines (current version, see below for proposed draft for consultation).

Medsafe last sought comment on a major revision of this guideline in 2018.

Updates are proposed to:

• Incorporate new or updated relevant guidance issued in New Zealand and overseas;
• Provide more clarity and options to those submitting regulatory applications supported by bioequivalence studies using overseas reference products; and
• Reflect and align Medsafe policy and approach with current global practice and recent local trends in this field.

To assist in the analysis of submissions, Medsafe will only accept submissions made through this consultation website. However, the full consultation document is attached below and can be viewed online, downloaded and/or printed.

All comments will be carefully considered and changes may be made as a result of the comments received.

To take part in this consultation, click on the online survey link below.