Medsafe has approved a generic brand of paliperidone injection under the new verification approval pathway, saving several months of work without compromising on safety.
The medicine, which was approved in 25 working days, was the first to be approved under the rule of two verification pathway which allows Medsafe to approve a medicine if it has already met the standards of two recognised overseas regulators.
Rather than repeating a full assessment, Medsafe focused on New Zealand-specific factors and verified that the medicine proposed for New Zealand was the same as the product approved overseas. The approach saved Medsafe around 10 months’ worth of assessment time.
Paliperidone is used to treat adults with schizophrenia and schizoaffective disorder, and has been approved as a first line treatment, allowing it to be one of the initial options offered to patients after a diagnosis.
There are currently three other brands of paliperidone approved in New Zealand, including one brand, Invega Trinza, which is funded. The newly approved medicine is a generic version of the original brand with the same active ingredient.
Introducing an additional brand provides more options for Pharmac and more competition in the New Zealand market.
Medsafe is currently in discussions with other companies that are interested in using the new expedited process and expects further applications soon.
The verification pathway came into effect in July 2026 and brought New Zealand in line with similar approaches in Singapore and the United Kingdon, where regulators work with trusted international partners to fast-track approvals while still maintaining strong safeguards.
The pathway is one important way Medsafe reduces duplication in its work and helps speed up access to medicines for patients.
