Revised: 3 May 2013

Approval Process and Safety Monitoring

All medicines carry risks along with the potential benefits of using them. When a medicine is approved for use from clinical studies many of these risks are known; however as the use of the medicine increases more information on its safety profile becomes available. Medsafe monitors this information to ensure that the medicine remains acceptably safe for use in New Zealand.

This section of the website provides information for consumers on how medicines are approved in New Zealand and how Medsafe monitors safety.

Medsafe's Evaluation and Approval Process

Information on the approval process for medicines in New Zealand.

Medicines Safety and Pharmacovigilance

Information on pharmacovigilance and how medicine safety is monitored (pharmacovigilance).

Medicine Safety

More information about adverse reactions to medicines.

Vaccine Safety

More information about adverse reactions to vaccines.