The European Medicines Agency (EMA) and the European Commission's Directorate-General for Health and Food Safety (DG SANTE) have concluded a working arrangement with New Zealand's Ministry of Health for collaboration and exchange of information on therapeutic products and medicinal products. The arrangement, published on 8 July 2026, establishes a framework for regulatory cooperation between the parties.
The document outlines mechanisms for sharing non-public information related to the safety, quality, and efficacy of medicines and therapeutic products. It is designed to facilitate mutual recognition of inspections, exchange of pharmacovigilance data, and coordination on scientific advice. The arrangement does not create legally binding obligations but sets out practical procedures for collaboration.
This is the first formal cooperation agreement between the EU and New Zealand specifically covering medicinal products. It builds on broader EU-New Zealand relations, including the EU-New Zealand Free Trade Agreement, which entered into force in 2024 and includes provisions on regulatory cooperation in pharmaceuticals. The working arrangement is expected to reduce duplication of regulatory efforts and speed up access to medicines for patients in both jurisdictions.
For EU regulators, the arrangement means closer alignment with New Zealand's pharmaceutical oversight, potentially lowering administrative burdens for companies seeking market access in both regions. For New Zealand, it provides access to EU expertise and data, particularly in pharmacovigilance. Pharmaceutical companies operating in both markets may benefit from streamlined inspection processes and shared scientific assessments, though they will still need to comply with separate marketing authorisation procedures. Patients in both regions could see faster availability of new therapies as a result of reduced regulatory delays.
The working arrangement will be implemented by joint committees and regular exchanges between EMA, DG SANTE, and the New Zealand Ministry of Health. No specific timeline for operationalisation has been announced.