Published: 2 September 2015

Therapeutic Products Regulatory Regime

Prescriber Update 36(3): 35
September 2015

The New Zealand Government is currently developing a new, comprehensive domestic regulatory regime to regulate therapeutic products. This follows the cessation of the Australia New Zealand Therapeutic Products Agency (ANZTPA) project.

The new regulatory regime will replace the Medicines Act 1981, and is intended to cover medicines, medical devices, and cell and tissues. The new regulatory regime will support and enable the delivery of healthcare and disability support services now and as they evolve into the future.

The objectives of the new regulatory regime include the need to be an efficient regulator and be cost effective. In addition, there needs to be flexibility in the legislation to future proof regulation with emerging technology. The benefits of aligning regulation with international standards are clear and this is a key objective.

A website is being developed and there will be opportunities for all groups to be consulted throughout the process. The Medsafe website will provide links to this website.