Source: New Zealand Government
Paliperidone is the first medicine to be approved in New Zealand via the expedited ‘Rule of Two’ pathway, says Associate Health Minister David Seymour.
“The ‘Rule of Two’ medicines approval pathway was introduced last year. It allows medicines to be approved within 30 days if the product has approval from two recognised overseas jurisdictions,” Mr Seymour says.
The policy is starting with recognising medicine regulators from Australia, the United States, Canada, the United Kingdom, the European Union Medicine Agency, Singapore and Switzerland.
“Medsafe has approved Paliperidone in 25 working days using the ‘Rule of Two’. This is around 10 months’ faster than expected without the ‘Rule of Two’,” Mr Seymour says.
“Rather than repeating a full assessment, Medsafe focused on verifying that the medicine proposed for New Zealand was the same as the product approved overseas and assessed any factors relevant to its use in the New Zealand context.
“The medicine is a paliperidone injection used to treat adults with schizophrenia and schizoaffective disorders.”
Paliperidone has been approved as a first line treatment, meaning it can be one of the initial options offered to patients after a diagnosis.
“This first approval shows the pathway works in practice, and can significantly reduce approval times without compromising on safety standards,” Mr Seymour says.
“Medsafe has already had positive discussions with several more companies interested in using the new process, and expects further applications soon.”
Original source: https://nz.mil-osi.com/2026/11/12/medsafe-approves-first-medicine-using-the-rule-of-two-pathway/