Medsafe approves first medicine using the ‘Rule of Two’ pathway
New Zealand’s Medsafe has approved the first medicine, Paliperidone, under the expedited ‘Rule of Two’ pathway, cutting approval time by about 10 months while maintaining safety standards.
New Zealand’s medicines regulator Medsafe has approved Paliperidone, the first medicine to use the ‘Rule of Two’ expedited pathway. The pathway allows faster approvals for medicines already approved by two recognised overseas regulators. Medsafe assessed the medicine’s suitability for New Zealand rather than repeating a full evaluation, focusing on consistency with overseas approvals and local factors.
Associate Health Minister David Seymour highlighted the policy’s introduction last year, enabling approvals within 30 days for eligible medicines. The pathway initially recognises regulators from Australia, the United States, Canada, the United Kingdom, the European Union Medicine Agency, Singapore and Switzerland. Medsafe completed the approval of Paliperidone in 25 working days, a process typically taking around 10 months without the expedited pathway.
Paliperidone has been approved as a first-line treatment, meaning it can be offered early to patients after diagnosis. The approval demonstrates the pathway’s practical effectiveness while maintaining safety standards. Medsafe’s verification process ensured the medicine met New Zealand’s requirements without duplicating overseas assessments.
Medsafe has reported positive discussions with additional companies interested in using the ‘Rule of Two’ pathway. The regulator expects further applications to follow, indicating growing industry engagement with the expedited process.