New Zealand Draft Therapeutics Product Bill: Are You Prepared?

March 8, 2019 Becky Hurt

By: Angela McGillivary, Principal Consultant, Parexel Consulting

On the 14th December 2018 the New Zealand government issued a draft Therapeutics Product Bill, public consultation on the draft Bill before it is introduced to parliament closes on the 18th April 2019.

The draft bill together with a consultation guide can be found on the ministry of health website https://www.health.govt.nz/publication/therapeutic-products-regulatory-scheme-consultation

Why is it being introduced?

The Therapeutics Product Bill is being brought in to replace the Medicines Act 1981.

The Medicines Act 1981 is outdated inflexible and there are many gaps in its coverage in respect to the range and complexity of the ever-increasing number of different therapeutic products. The Act does not cover cell and cell tissue products and does not adequately cover medical devices.

What will it look like?

This Bill brings New Zealand in line with other developed countries and will cover

  • Medicines, including cell and tissue products
  • Active Medicinal Ingredients
  • Medical Devices
  • Type 4 products, for future therapeutic products

The bill however does not cover natural products, options are being considered for a separate regulation.

The Bill will be a principles-based legislative framework and will contain less operational detail. There will be four tiers of legislation:

  1. Therapeutic Products Act: Legislative instrument which follows the parliamentary process
  2. Regulations: Legislative instrument made by the Governor General
  3. Rules: Legislative instrument made by the regulator
  4. Regulator’s Notices: Non-legislative instrument made by the regulator

What does this mean for Industry?

Below are some examples

Medicines:

 

Therapeutics Product Bill

Medicines Act 1981

Product Approval

Product approval would be required to import product

Product approval required before distribution

A person or cooperate body applying to the regulator for product approval has to meet certain criteria as set out in the bill (section 97 “Criteria for sponsor of approved product”)

Criteria not as clearly set out leading to sponsors not being suitability qualified leading to delay in post marketing surveillance

Approved and rejected products will be listed in public register

Approvals currently issued in a Gazette

Product Changes

Now classified as Major and Minor and similar to Australian and European guidelines.

Minor changes would be either notified or be part of 6 or 12 monthly annual report.

Major changes would mean a change to the product and would require product approval before release on the market

Currently handled as self-assessable

Medical Devices

Medical Devices are only currently regulated through post marketing controls, the new bill will align with the Global Harmonisation Taskforce (GHTF) and the International Medical Device Regulators Forum (IMDRF). There will be two categories for medical devices Invitro diagnostic medical devices (IVDs) and medical devices that are not IVDs.

Cell and Cell Tissue

The use of cells and tissue is covered under the Human Tissue Act 2008; however it does not cover the use of cell and tissues for therapeutic use. The new Bill will follow the European approach and would mean that tissue establishments would have to be licensed and engineered cells and tissues would require product approval.

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