Red light on ANZTPA

The establishment a joint therapeutic products regulator between Australia and New Zealand will no longer continue.

Recently the Australian and New Zealand governments announced their agreement to cease the Australia New Zealand Therapeutic Products Agency (ANZTPA). After conducting a comprehensive review of progress and assessment of the costs, it was determined that the mutual Agency was not going to benefit either country.

Although work on ANZTPA will cease, the ministers of both countries agreed to continue cooperating on the regulation of therapeutic products where there are mutual benefits for consumers, businesses and regulators.

Both, the Therapeutic Goods Administration (TGA) and the Medicines and Medical Devices Safety Authority (Medsafe) will continue to explore other Trans-Tasman regulatory harmonisation activities, such as the development of new information sharing agreement and formalising mutual recognition of good manufacturing practice audits. This work will increase the potential for regulatory alignment over time to reduce compliance costs.

It has been determined that each country will now proceed with its own domestic therapeutics regulatory reform programme while remaining open to future cooperation activities.

For any regulatory enquiries regarding medical devices and IVDs contact KD&A on +61 4 11 101 392 or email us at kdent@kdas.com.au.