The passing of the Therapeutic Products Act marks the most significant change to the regulation of medicines, medical devices and natural health products in nearly 40 years.
On 26 July 2023 the Therapeutic Products Bill received Royal assent, becoming the Therapeutic Products Act (2023).
Most provisions in the Act will not commence (come into effect) until mid-2026. Until then, Manatū Hauora (the Ministry) will be busy developing the necessary rules and regulations to support the new therapeutic products regulatory regime. The Ministry will also be establishing the Regulator to administer the Act.
The new regime will be flexible enough to support innovation, while ensuring effective control over quickly evolving health technologies. It will also align with international standards and uphold the quality of regulation currently carried out by the Ministry.
As well as replacing and modernising the regulatory arrangements for medicines, the Act provides fit-for-purpose regulation of medical devices, and cell, gene and tissue therapies, which are currently not fully regulated.
The Act also covers natural health products. These will have their own regulations under the Act.
High level timeframes
- 30 Nov 2022: Introduced to Parliament by Minister Little (and referred to Health Committee in December)
- Mid-Dec 2022 to 5 March 2023: Public submissions on the Bill open (16,500 public submissions received)
- 13 June 2023: Health Committee reports back with proposed amendments and the Government announces an exemption scheme for small scale NHP manufacturers, and that in most cases rongoā will not be regulated under the Act.
- 18 July 2023: Committee of the Whole House
- 19 July 2023: The Bill passes its third reading in the House.
- 26 July 2023: The Bill receives Royal Assent and becomes the Therapeutic Products Act (2023).
- 1 September 2026: All the Act's provisions must be in place.
Aims of the Act
- The Act aims to protect, promote, and improve the health of all New Zealanders by providing for the:
- acceptable safety, quality, and efficacy of medicines
- acceptable safety, quality, and performance of medical devices
- acceptable safety and quality of NHPs, and that any health benefit claims are supported by scientific or traditional evidence.
- It will regulate how products are manufactured, tested, imported, promoted, supplied, and exported. This will include medicines from general sale products (like paracetamol) to gene, cell and tissue therapies, and medical devices (from tongue depressors to implantable pacemakers).
- Medical devices and gene, cell and tissue therapies are currently not fully regulated in New Zealand so the Act seeks to address this. The regulation of clinical trials will also be made more robust.
- The Act provides a risk-proportionate approach. Pre-market controls will provide assurances that products are made to the proper standards, while in-market and post-market controls will enable a timely response if safety issues arise.
What happens next?
Implementing the Act is a large-scale and complex programme of work.
It includes three major workstreams:
- Secondary legislation – creating policy, rules, regulations, and regulatory instruments to support the new therapeutic regulatory regime
- Secondary legislation will be consulted on.
- IT platform – building a stable and scalable IT platform to support regulatory functions.
- The Regulator – appointing an independent statutory officer as the Regulator and establishing a branded business unit within the Ministry of Health.
The scale, scope and complexity of work remaining to be undertaken before 2026 is significant and will require extensive consultation and engagement with the sector.