New Zealand’s medicines regulator Medsafe has approved the first medicine through the country’s expedited “Rule of Two” pathway, clearing a treatment for schizophrenia and schizoaffective disorders in just 25 working days.
The medicine is paliperidone, an injection used to treat adults with schizophrenia and schizoaffective disorders. Associate Health Minister David Seymour announced the approval on Thursday, 12 November, saying it was the first medicine to be approved in New Zealand via the new pathway.
The “Rule of Two” pathway was introduced last year. It allows medicines to be approved within 30 days if the product has already been approved by two recognised overseas regulators. The policy recognises regulators from Australia, the United States, Canada, the United Kingdom, the European Union’s medicines agency, Singapore and Switzerland.
“Medsafe has approved paliperidone in 25 working days using the ‘Rule of Two’. This is around ten months faster than expected without the ‘Rule of Two’,” Mr Seymour said, presenting the approval as proof that the new system works as intended.
Paliperidone has been approved as a first-line treatment, meaning it can be one of the initial options offered to patients after a diagnosis. For people living with schizophrenia and schizoaffective disorders — conditions that affect thinking, mood and perception — faster access to a new treatment option can make a real difference to care.
The speed of the decision is the point of the reform. Traditional medicines approval in New Zealand has been a lengthy process, with assessments often taking many months as regulators reviewed safety and efficacy evidence from scratch. The “Rule of Two” approach instead relies on the work already done by two trusted overseas agencies, letting Medsafe focus its own assessment on whether the medicine is suitable for New Zealand patients.
Supporters of the change argue that New Zealanders have waited too long for medicines already available in comparable countries, and that the new pathway will close that gap without lowering safety standards. The two-regulator requirement is designed to provide a double check: a medicine must have passed muster in two separate jurisdictions before it can be fast-tracked.
Critics of fast-track approvals in other countries have warned that speed can come at the cost of scrutiny, and that regulators should retain the ability to look closely at evidence rather than simply accepting overseas decisions. The New Zealand government’s answer is that Medsafe still makes its own decision, and that the pathway applies only where two recognised regulators have already approved the product.
The paliperidone approval is a test case for the wider policy. If the pathway continues to deliver approvals in weeks rather than months, more medicines could follow quickly — and the government will be able to point to a concrete result rather than a promise.
For patients and clinicians, the practical effect is straightforward: a new first-line treatment option for schizophrenia and schizoaffective disorders is now available in New Zealand, roughly ten months sooner than it would have been under the old system.
The government has not said which medicine will be next through the pathway, but the first approval sets a precedent that other applicants are likely to follow.
