
The Government will introduce faster approval times for medicines that meet its 鈥淩ule of Two鈥�, associate Health Minister David Seymour announced today.
Seymour said Cabinet has agreed to allow Medsafe to give the green light to 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
鈥淣ew 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鈥� safety, we don鈥檛 need to delay patients鈥� access by doing the exact same tests.鈥�
He said the new approach was 鈥渃ommon-sense efficiency that costs nothing鈥�.
鈥淚t 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.鈥�
It comes after the Government altered Pharmac鈥檚 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.
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