Therapeutic products regulatory regime

We are working on a modern, comprehensive, cost effective regulatory regime for therapeutic products and natural health products in New Zealand, which will replace the Medicines Act 1981.

Therapeutic products (medicines, medical devices and biologics) are used by New Zealanders in their daily lives, and in all parts of the health system.  It is an umbrella term for products that are intended to be used in or on people for a therapeutic purpose to prevent, diagnose, monitor, alleviate, treat, or cure a disease, ailment, defect, or injury.Therapeutic products can also present serious risks of harm, especially if used inappropriately. Ensuring the benefits of therapeutic products outweigh possible risks of harm to consumers is fundamental to the delivery of high quality health and disability services.

The Government is currently developing a new therapeutic products regulatory regime.  Legislation is expected to be introduced to Parliament later in 2022.

The Therapeutic Products Bill will take on board sector feedback to consultation undertaken in recent years, the work underway on the health and disability system reforms, as well as new health technology changes and also lessons from COVID-19.

The Bill will regulate how products are manufactured, tested, imported, promoted, supplied, and exported. This will include:

  • regulating medicines from general sale products like paracetamol to gene, cell and tissue therapies,
  • and medical devices that range from tongue depressors to implantable pacemakers.

Both medical devices and gene, cell and tissue therapies are currently not fully regulated in New Zealand.

Natural health products are also going to be included under the Bill, though they will not be regulated as therapeutic products and will have their own regulations. More information is on the Natural health products page

The new legislation aims to provide New Zealanders with the assurances they would expect about the quality, safety and efficacy of therapeutic products. It will help deliver better health outcomes for people and ensure consumer safety.

The new scheme will align with international best practice and will be future proofed with flexibility to ensure effective control over new technologies,

 It will also be as efficient and cost-effective as possibleand uphold the quality of regulation currently carried out by the Ministry of Health. This will help to:

  • assure the safety of products used in healthcare delivery in New Zealand
  • ensure alignment with international best practice which will support imports and exports

Have your say

When the Bill reaches Select Committee stage, expected to be at the end of 2022 or early 2023, there will be an opportunity for people to have their say. There will also be further opportunities during the consultation on the regulations.

Release of decisions on the regime

Consultation on the draft Therapeutic Products Bill closed in April 2019. See these previously released decision documents:

Released 17 March 2022

Released 14 December 2018

Minutes from November 2015 and March 2016 Cabinet papers

Released 28 April 2016

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