Quicker Medsafe approval times for medicines already in use overseas - David Seymour

Associate Health Minister David Seymour. Photo / Marty Melville

The Government will introduce faster approval times for medicines that meet its “Rule of Two”, associate Health Minister David Seymour announced today.

Seymour said Cabinet has agreed to allow Medsafe to give the green light for these medicines in under 30 days or less.

The Rule of Two refers to medicines that have gained approval from two recognised jurisdictions.

The policy would start with the main countries Medsafe currently recognises, which are Australia, the United States, Canada, the United Kingdom, the European Union, Singapore and Switzerland, Seymour said.

The changes will be in action by 2026, he said.

Pharmac Minister David Seymour. Photo / Mark Mitchell

“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 new approach was “common-sense efficiency that costs nothing”.

“It can shave months off the approval process. A perfect example of this was with a treatment for asthma which could have been approved by the end of 2022 under this pathway, but was not approved until 16 months later in May 2024.”

It comes after the Government altered Pharmac’s process so it could assess a funding application at the same time Medsafe was assessing the application for regulatory approval.

And last year, changes were made to allow cold and flu medicines containing pseudoephedrine to be sold over the counter at pharmacies without a prescription. A consultation with a pharmacist is required.

Julia Gabel is a Wellington-based political reporter. She joined the Herald in 2020 and has most recently focused on data journalism.