The process in New Zealand begins with the release of data supporting the introduction of a new medicine. Our regulatory team here in NZ then engages with Medsafe. Medsafe makes the call on efficacy (effectiveness) and safety of all medicines licensed in NZ. This is an essential step in bringing the most appropriate medicines to the right patients and involves large dossiers of data requiring expert regulatory analysis.
“In New Zealand, every medicine sold must first be registered with the Ministry of Health (Medsafe), and it is my job to ensure this is the case. I review the medicine dossier against NZ legislation and guidelines and determine a strategy to bridge any gaps. I adapt sections of the dossier to fit local requirements before finally submitting the registration application to Medsafe for review.
Medsafe evaluates aspects such as the manufacturing and testing of the medicine (quality) as well as the benefit-risk profile (efficacy and safety) of the medicine as observed in clinical trials and also in the post-market setting for registered medicines. Once registered, the medicine can then be made available to New Zealand patients.”
Following Medsafe’s review and approval, our small but expert team ensure we understand fully what our clinicians here in NZ want for their patients. We then engage with PHARMAC to negotiate the best deals that we can bring to NZ, fulfilling contracts of supply, and ensuring a high quality product reaches the customer and our clinicians have the essential information they require to prescribe and administer these medicines.
Once submitted, PHARMAC has an established process for deciding which medicines to fund. Of all our registered medicines, two thirds are funded by PHARMAC.
Click here to understand how medicines are made available for Kiwis.
