25 September 2024
By Jody Hopkinson, Pharmacy Today
The pharmaceutical industry and a medicines reclassification expert have welcomed the Government’s proposal to update Medsafe’s approvals process, but some details still need to be ironed out.
Associate health minister David Seymour has been working on streamlining medicines approvals since the Coalition Government was elected last year.
Last week, in a speech to Consumer Health Products New Zealand (CHPNZ), Mr Seymour gave an update on the work programme endorsed by the Cabinet in June. The programme includes several actions to make the medicines approvals system more efficient.
For example: Changing Medsafe’s approval process from calendar days to business working days in the short term, upgrading Medsafe’s IT structure in the mid-term, and focusing on regulatory harmonisation in the long term.
New approval pathway proposed
The big change is creating a two-country rule 30-day pathway. This proposed pathway means that if a company puts forward a product for approval in New Zealand and two similar countries have approved that product for OTC or prescription use, Medsafe should also approve the medicine within 30 days.
The proposal recognises the US Food and Drug Administration, the European Medicines Agency and the Australian Therapeutic Goods Administration (TGA) as examples of recognised overseas authorities.
A briefing paper from Mr Seymour’s offices outlined several safeguards to ensure medicines meet international standards for safety and efficacy under the new pathway.
The pharmaceutical company must also provide evidence that the medicine being supplied is identical to that approved by trusted regulators.
Medsafe requirement is ‘unworkable’
CHPNZ chair Scott Milne says he welcomes Mr Seymour’s proposals, but one of Medsafe’s requirements is too restrictive.
Mr Milne says Medsafe has made the two-country pathway unworkable by requiring the process to use foreign regulatory bodies only that have produced evaluation reports for the product being considered. These reports record all communications and information a regulatory body has gone through in approving a medicine.
“Only Canada and perhaps the UK still do these. Medsafe does them, but they are out of step with the rest of the world. Australia does not and the TGA is the main body we would want to harmonise with. So Medsafe’s proposed working would exclude Australia,” Mr Milne says.
Even without evaluation reports, the regulatory bodies would still share all the information on the processes, he says.
“We’re not scared of disclosure, just not in that specific format.”
One-country rule, 30-day pathway
Mr Milne says Australia and New Zealand’s medicinal needs are remarkably similar.
“What is the difference between how a headache needs to be treated in Melbourne as it would be for the population of Auckland?”
CHPNZ proposes a one-country rule with a 30-day approval pathway, meaning that if a product like a paracetamol-ibuprofen tablet is approved by the TGA and sold in Australia, the same tablet would automatically qualify for availability in New Zealand.
The CHPNZ is tired of Medsafe regarding them as “prescription-lite”, says Mr Milne.
“We want OTC medications to be safe and available but not to be subject to such rigorous regulations as prescription medicines.”
Medicines NZ supports proposal
Medicines NZ similarly supports proposed changes, says its chief executive officer Graeme Jarvis.
“We are extremely encouraged by the minister’s efforts to enhance regulatory approval processes at Medsafe, including through the increased use by Medsafe of regulatory reliance, ie, the leveraging of regulatory assessment work already undertaken by competent and trusted international regulators, to support decision-making.”
Changes not controversial
Pharmacist and Pharmacology and Therapeutics Advisory Committee deputy chair Rhiannon Braund says it is possible to speed up the Medsafe process by using several non-controversial measures.
“Working more closely with the TGA to me is a very sensible approach, because the TGA is much more similar to what we have. It would make a lot of sense for us to have some harmonisation,” Professor Braund says.
She says a proposed upgrade of Medsafe’s IT system would be very much welcomed. Comparisons of Medsafe’s approval times with those of the TGA show that both agencies operate at much the same speed.
“These processes just take time, and that’s not just Medsafe’s fault either. There’s information they request, and it depends how long [it takes to] get information back, so it’s not always one-sided. That kind of information sharing is never one-sided.”
Professor Braund urged caution when it comes to working with the FDA.
“I hope David Seymour is learning that the FDA does not mean safe. It has quite a different approach to safety than Medsafe. In New Zealand, the responsibility for when things go wrong with medicines rests on ACC, so the Government bears responsibility.”
She also sat on the Medical Classification Committee, which recommends looking to countries with regulatory practices more closely aligned with New Zealand’s.
“We have more in common with Australia and Canada and the UK regulatory authorities.”
Thanks to Pharmacy Today for allowing this to be shared on CHPNZ.org.nz. Read the article on Pharmacy Today here and NZ Doctor here.