New Zealand

The European Commission's Directorate-General for Health and Food Safety (DG-SANTE) and EMA have in place a working arrangement with the New Zealand Ministry of Health since 2026. The Ministry of Health incorporates the New Zealand Medicines and Medical Devices Safety Authority, Medsafe.

The arrangement enables exchange of information on medical and medicinal products between the EU and New Zealand authorities, as part of their regulatory and scientific processes.

It is a significant step towards mutual recognition and regulatory harmonisation between both regions.

The working arrangement is in effect as of 6 July 2026.

Working arrangement

The arrangement is valid for an indefinite period of time, unless terminated by either party.

In line with this arrangement, EMA and the New Zealand Ministry of Health can exchange information in the following areas:

• Collaboration to exchange information on the quality, safety and efficacy of therapeutic and medicinal products, authorisation of clinical trials, product labelling and the development of policies and guidance
• Share information on compliance monitoring (e.g. data on adverse reactions or incidents), benefit-risk assessment of products, and the development of policies for regulating medicines and other therapeutic products on the market
• Work together on compliance and enforcement activities for medicines and other therapeutic products, including inspections, compliance checks, and risk assessments.

A working arrangement document is available:

Working arrangement for the collaboration and exchange of information on therapeutic products and medicinal products between DG SANTE/EMA and the New Zealand Ministry of Health

Mutual recognition agreement on GMP compliance

The mutual recognition agreement between EU authorities and their counterparts in New Zealand allows to:

• rely on each other's good manufacturing practice (GMP) inspections;
• waive batch testing of products on entry into their territories;
• share information on inspections and quality defects.

For more information on mutual recognition agreements and the scope of the agreement between EU and New Zealand, see:

• Mutual recognition agreements

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in July 2026.

See update history

8 July 2026

Page revised to include information on the signature of a working arrangement between DG-SANTE, EMA and the New Zealand Ministry of Health