Countries on the list are alrady approved by Medsafe. Photo: 123RF
Cabinet has approved a streamlined pathway for medicines approval, if a particular product has approval from two recognised overseas jurisdictions.
From early 2026, if a medicine is approved in two out of Australia, the United States, Canada, the United Kingdom, the European Union, Singapore, and Switzerland, it can be approved in New Zealand in less than 30 days.
Those jurisdictions are already recognised by Medsafe.
Associate health minister David Seymour said it meant people would be able to access new treatments more quickly.
"New cars are acceptable for the New Zealand market if they meet at least one of several foreign standards. We can apply the same principle to medicines. If other jurisdictions have already done the work and can ensure the products' safety, we don't need to delay patients' access by doing the exact same tests," he said.
The changes would be part of the Medicines Amendment Bill, which was introduced to the House on Monday.
Seymour said he would outline the proposed 'Rule of Two' regulatory pathway for industry and public feedback, through the Select Committee process.
Draft criteria for the regulatory pathway rules would likely relate to ensuring manufacturing sites had evidence of good manufacturing practice compliance which was valid to Medsafe's satisfaction.
It would also ensure if a product was a generic or biosimilar prescription medicine, the innovator or reference product was identical to that approved for New Zealand.
