Australia and New Zealand Implement Harmonized OTC Regulatory System

Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe have announced that a new over-the-counter (OTC) drug process for the evaluation of new and changed OTC medicines will be implemented in each country as of 15 April 2013.

Companies will have a one-year transition phase to become familiar with the new submission formats, during which time OTC products already marketed will remain on the market and sponsors of new OTC products will comply with the current process outlined in the Australian Regulatory Guidelines of OTC medicines. Both TGA and Medsafe will undertake a review of the experience gained from the use of the new system after 18 months to ensure that the harmonized reforms are delivering as anticipated.

This represents a further step toward a fully harmonized and integrated joint regulatory framework between Australia and New Zealand that is to commence in July 2016 under a new merged regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA). The initial step toward regulatory harmonization by was taken in 2003 when the two countries concluded a treaty on "the establishment of a joint scheme for the regulation of therapeutic products."