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

Overview

This consultation is aimed at sponsors* of medicines that are approved for use in New Zealand and organisations involved in pharmacovigilance activities (ie, on behalf of sponsors).

Medsafe is seeking your feedback on proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Pharmacovigilance (the Guideline).

Medsafe last sought comment on a revision to the Guideline on the Regulation of Therapeutic Products: Pharmacovigilance in 2020 (Ed 2.2) (PDF, 424 KB, 35 pages).

We are proposing a number of updates to the Guideline to aid sponsors in their pharmacovigilance obligations.

Notable updates include:

• new information relating to the process of collecting and reporting of suspected adverse reactions in New Zealand
• new information about what constitutes a significant safety issue, and the introduction of the ‘other safety issue’ category.

Other updates throughout the Guideline reflect previous discussions with sponsors and changes to Medsafe’s internal processes.

The ‘Related’ section below contains the draft Guideline, plus a document highlighting the proposed changes and a copy of the consultation questions.

Please use this consultation website to provide your comments/suggestions on the Guideline. We will only accept submissions via this method.

When analysing the submissions, we will consider all comments/suggestions and update the Guideline accordingly.

We will publish the outcome and updated regulatory Guideline on the Outcome of Consultations web page on the Medsafe website.

*A sponsor is defined as an individual, company, institution, or organisation that is responsible for the medicinal product in New Zealand.