Pharmaceutical Business review

Australia, New Zealand introduce new process to evaluate OTC medicines

The move marks a major step in setting up a single Trans-Tasman regulatory agency for therapeutic products.

New Zealand Health Minister Tony Ryall, in a joint statement, said for the past 18 months regulators, industry and consumers on both sides of the Tasman have been working together to streamline and harmonise processes for approvals for over-the-counter (OTC) medicines.

"The common approach to processing applications for medicines sold over the counter signals a significant step towards establishing the new agency," Ryall added.

The new processes will be rolled out over the next 12 months.

Australian Health and Ageing Parliamentary Secretary Shayne Neumann said that the reforms introduce more predictability for companies wishing to supply OTC medicines in Australia and New Zealand.

"The new processes are largely administrative but will lead to greater transparency and a faster process without compromising the level of scrutiny applied to ensure OTC medicines meet the exacting standards expected by all consumers," Neumann added.

Scheduled to be launched later in 2013, Trans-Tasman early warning system will alert health professionals and consumers to safety concerns identified with medicines and medical devices.