Almost what the doctor ordered…

Long-awaited reform of therapeutic product regulation is underway in Aotearoa New Zealand following passage of the Therapeutic Products Act 2023 but there is still a way to go.

In this article we summarise the timing and implementation of the Act, what is covered by the regime and key changes to the existing regime including:

• Market authorisations — the process to bring medicines, medical devices and NHPs to market.
• Controlled activities — what types of activity will be captured.
• Advertising — significant changes to the existing requirements. 
• Increased liability for senior managers — a more onerous approach to potential liability. 
• Enforcement — the teeth of the new regime including more significant penalties.
• The new Therapeutic Products Regulator.

These are just the highlights. If you have any questions or concerns about how the new Act will impact you or your business, please get in touch with our experts.