New Zealand – Medsafe Clarifies Process for Extending the Shelf Life of Reference Standards

Medsafe has updated its guideline on obtaining approval for new and changed medicines. The latest text features a new section setting out the process for extending the shelf life, expiry or retest date of a reference standard.

Manufacturers use reference standards as comparators in determinations of the biological activity and potency of biological test samples, making them central to quality control. In New Zealand, the process is described in a data requirement annex to the guideline on obtaining approval for new and changed medicines.

This week, Medsafe updated the guideline, notably by adding a new section to the data annex about making changes to the shelf life, expiry or retest date of reference standards. The new section splits reference standards up into those with and without a protocol for the retest or expiry date…