Reform of the therapeutics products regulatory regime
In March, the Ministry of Health (MoH) confirmed the reform of the therapeutic products regulatory regime, including natural health products (NHPs), is a “key priority” this year.
A number of revisions to the Bill are still needed and some areas require further work – such as biologics, Te Tiriti provisions, market authorisation and post-market measures, the MoH statement about the Bill says.
MoH adds the purpose of including NHPs with therapeutic products is consumer safety and ensuring quality, while supporting industry and exporting.
When the Bill reaches Select Committee stage, by the end of the year or early next year, there will be another opportunity to submit feedback. Once the Bill receives Royal Assent, MoH says it there will be two to three years before the scheme commences and the regulations are set.
Scott Milne expects submissions will address timeframes for regulatory processes, which have become “protracted, complex and expensive.”
“Innovation and new product development have been stifled by regulatory pressures – some resulting from Covid and some from outdated provisions in the old Act,” he says. “A new approach where all parties are made accountable is overdue.”
NHPs versus therapeutic products
NHPs will not be regulated as therapeutic products or as foods but have their own regulations under the Bill.
- a broad group of products intended to support health and wellbeing, which are not medicines or foods
- Examples include – garlic capsules, glucosamine capsules, magnesium tablets, herbal products (e.g. echinacea and herbal teas), and kawakawa balm
- The Bill will be designed to ensure there is a clear distinction between NHPs, medicines, foods, and cosmetics
Therapeutics products, in contrast are medicines and medical devices, including biologics, used by New Zealanders in their daily lives, and in all parts of the health system. They’re also used to treat and prevent COVID-19
The Bill includes regulating medicines from general sale products like paracetamol to gene, cell and tissue therapies, medical devices that range from tongue depressors to implantable pacemakers.