Welcome move: New Zealand health ministry plans to regulate supplements via self-assessment - Updated
The ministry has been working on drafting the Therapeutic Products Bill and recently announced the planned market authorisation process for therapeutic products.
There are five different processes drafted, of which, natural health products have been categorised under the self-assessment / declaration process.
According to the announcement, the process is “an ongoing ‘automatic assessment of information and authorisation carried out by a system” and is applicable to natural health products, lowest-risk medical devices, and sunscreen.
The other four processes are 1) special access for enabling access to products in special circumstances, such as the treatment of life-threatening or rare disorder diseases, 2) provisional – a temporary authorisation which requires preliminary evidence of efficacy and safety, 3) standard (full) – a comprehensive evaluation for medium to high risk therapeutic products, and 4) standard (expedited) – a shorter version of full evaluation and requires evidence of overseas approvals issued by comparable regulators.
“The Bill will enable the regulator to design flexible, risk-proportionate pathways for applicants to seek product approval.
“Each pathway will be designed to achieve an optimal level of regulatory oversight, taking into account the need to provide for patient safety and timely accessibility of products.
“These pathways provide a framework that will address the specific nature of the product and the circumstances,” said the MOH announcement.
At the same time, natural health products could be a non-prescription OTC therapeutic product, a pharmacist and pharmacy-only medicines, and foods and cosmetics.
In response, industry body Natural Health Products NZ (NHPNZ) welcomed the plan, commenting that this is the “only logical risk and cost proportionate pathway for low-risk products such as natural health products.”
“We are encouraged to see in the MoH's diagrams clear recognition that NHPs can be therapeutic and are hopeful that our extensive discussions with the MoH will result in all of the types of claims permitted for NHPs being enabled in the new legislation.”
At the moment, the Bill is at the drafting stage.
It is expected to be formally introduced later this year and reached the Select Committee stage early next year, where there would be an opportunity for public feedback.
In March, the New Zealand government announced that natural health products would not be regulated as therapeutic products and could only make health benefit claims, which have led to an outcry from the industry, which argued that this could undermine local products in international market.
Update: August 18: By Gary Scattergood: At today's NHPNZ annual summit held in Napier, and attended by NutraIngredients-Asia, several industry players expressed concern that they were unlikely to see the Bill before it was put to parliament. The Ministry of Health believes that further consultation is not required, given that it has 'engaged significantly' over recent years, industry leaders from Vitaco, Anagenix and the trade association itself believe it is a missed opportunity that they can't have advanced sight of the bill to iron out any concerns. They also called on the government to do more to help NZ firms boost their exports by introducing an 'export-ready' listing pathway. Without this, many believe the industry will struggle to fulfil its potential on the global stage.
