Part 11. Clinical trials – regulatory approval and good clinical practice requirements

NZNO seeks member feedback on the Update to the Guideline on the Regulation of Therapeutic Products – Part 11: Clinical trials.

The revision reflects changes in technology, and addresses which have arisen since the guidelines were last updated early 2015. It clarifies the requirement for Clinical Trial Site Notification.

Please find a link to the update here: https://consult.health.govt.nz/medsafe/guideline-regulation-therapeutic-products-part-11/consultation/

Send feedback to [email protected] by 31 July 2018