New Zealand’s medicines regulator has approved a generic paliperidone injection under a new pathway that uses assessments by trusted overseas authorities. It is the first medicine to be approved through the route, known as the Rule of Two.
The regulator said the approval took 25 working days. It estimated that the verification approach saved around ten months of assessment time compared with what would otherwise have been expected. That is an estimate for this application, not evidence that every medicine using the pathway will save the same amount of time.
Paliperidone is used to treat adults with schizophrenia and schizoaffective disorder. The regulator said it is approved as a first-line treatment, meaning it can be among the initial options considered after diagnosis. The announcement concerns a particular generic injection, rather than a newly discovered medicine or the first approval of paliperidone in the country.
Three other brands of paliperidone were already approved in New Zealand, the regulator said. One of them, Invega Trinza, is publicly funded. The announcement did not establish whether the newly approved generic brand would be funded, when it would be supplied or what it would cost.
How the verification pathway works
The pathway is an additional option for companies applying for approval. It was introduced through legislation passed in 2025, with the detailed rules taking effect on 3 July 2026. It does not replace the existing routes for assessing new medicines.
To qualify, a medicine must have full marketing authorisation from at least two recognised overseas regulators. The product proposed for New Zealand must be identical in all material respects to the overseas-approved medicine, although the rules allow some minor differences. The intended therapeutic purposes must also match those approved by the recognised authorities.
Recognised authorities include regulators in Australia, Canada, the United Kingdom, the United States, Singapore and Switzerland, as well as the European Medicines Agency. The rules set further conditions: for example, the overseas authorisations relied upon must have been granted no more than four years before the New Zealand application.
Rather than repeating a full assessment for the paliperidone application, the regulator said it checked that the proposed product was the same as the one approved overseas and considered factors relevant to its use in New Zealand.
Applications are not eligible for the pathway if, among other conditions, a recognised regulator has rejected or withdrawn the medicine’s authorisation for reasons of quality, safety or efficacy. Nor is the route intended for medicines requiring an independent local assessment of their benefit and risk because of particular New Zealand health considerations.
Guidance sets out an approval decision by the thirtieth working day of the evaluation stage. Time spent waiting for an applicant to respond to a request for information can stop that clock, and an application first goes through a separate validation stage. The timetable therefore should not be confused with a guarantee that every application is completed within 30 working days of submission.
Medicines approved through verification remain subject to post-approval oversight. The regulator’s guidance provides for checks on a sample of applications and for information to be requested after approval; consent can also be subject to conditions, suspension or revocation.
Approval and funding are separate
Regulatory approval and public funding are different decisions in New Zealand. The medicines regulator assesses applications for approval, while a separate government agency decides which medicines to fund within its budget. A funding process can take place alongside regulatory assessment, but approval alone does not establish a subsidy.
The funding agency says its decisions involve clinical advice, assessment of costs and benefits, comparison with other options and, where appropriate, negotiation with suppliers. Its process does not have a fixed timeframe for every application.
The regulator said it was discussing the verification route with other companies and expected further applications. It did not announce another approval or a timetable for making this particular generic injection available to patients.
