Monthly Archives: %sNovember 2014

Australia and New Zealand Therapeutics Product Agency (ANZTPA) – What Next?

Again the proposed joint regulatory agency between Australia and New Zealand – the Australia New Zealand Therapeutic Products Agency (ANZTPA) has faltered. There has been discussion with regard to forming this joint agency since the initial agreement was signed between the two Governments in December 2003. The first attempt at establishing ANZTPA was unsuccessful […]

By |November 21st, 2014|Drug Regulation|0 Comments

Data exclusivity

Data exclusivity is a vexed issue: how to protect new innovations and additional clinical studies without the advantage of patent protection? Data Exclusivity in Australia is aimed at providing a 5 year window whereby a company can enjoy exclusive use of the data that they have generated without competition from generics.  The requirements are […]

By |November 13th, 2014|Drug Regulation|0 Comments