Australia Regulatory Update, July 2011

(Published July 2011)

We write you with several regulatory updates on Australasia. In addition to a redesign of the TGA website and the latest fee schedule, there are some exciting new developments in the effort to form a unified regulatory system between Australia and New Zealand. Additionally, we wish to announce a new Emergo Group service—Sponsor for New Zealand.

Redesigned TGA Website

In May of this year, the TGA rolled out a redesigned website. Although most of the content and navigation is the same, some URLs were changed in the redesign and users familiar with the older website will find that many links and bookmarks to the site are no longer valid.

The TGA has published a navigation guide and old-to-new site map to assist users in the transition. Please click here to see it.

We prefer a simple Google site search to locate new URLs, however. For example, simply visit Google and enter the search phrase “site:www.tga.gov.au argmd” in the search box to find the ARGMD guidance document.

Emergo Group Begins Sponsor Services in New Zealand

In response to increasing interest in the New Zealand market and the need for Sponsor assistance for manufacturers without a place of business in the country, Emergo Group is pleased to announce a new service for New Zealand Sponsor.

There is no regulatory hurdle to market access in New Zealand as there are no pre-approval requirements except for condoms and contraceptive devices; however, all devices must be registered in the WAND (Web Assisted Notification of Devices) database and, similar to Australia, this submission must be made and maintained by a local representative. Additionally, the New Zealand Sponsor is responsible for various post-market obligations and interfacing with the New Zealand Medicines & Medical Devices Safety Authority.

It should be noted that if/when the anticipated unification between the New Zealand and Australian regulatory systems is implemented, it is likely that only a single Sponsor will be required.

ANZTPA Back on Track

The initiative to create a joint, unified regulatory system between Australia and New Zealand—the Australia New Zealand Therapeutic Products Agency (ANZTPA) —is back on track after being shelved in 2007 because of disagreement on certain issues.

Full implementation of ANZTPA is scheduled to take place around 2016, with the phase-in of various elements of the plan over the next five years.

As of the return to the project, the two regulatory agencies have begun sharing information, resources, and working towards the next steps in the process. Eventually, the ANZTPA is planned to absorb and replace the two separate agencies with a single regulatory system and point of contact for industry.

More information on the ANZTPA is available on the TGA website.

We will monitor progress and hope that this iteration of ANZTPA will be accomplished successfully.

TGA Revised Fee Schedule

The TGA fee schedule for fiscal year 2011–2012 went into effect July 1st of this year. Most fees were increased by around 3.4%, making the annual renewal fee for class IIa and IIb devices $840 (AUD), up from $810 in the previous fee schedule.

A complete list of current fees is available at the TGA website.

Closing Thoughts

We hope that this information expands your knowledge of the regulatory activities in Australia and New Zealand. The Emergo Group New Zealand Sponsor service was initiated prior to the ANZTPA announcement, so we will certainly be monitoring the activities of ANZTPA and are optimistic that this time implementation will occur. Lastly, TGA issued version 1.1 of ARGMD in May and it is available from the website.

As always, please feel free to contact us.

Enjoy the summer (or winter, if you’re in Australasia),

Evangeline Loh, PhD RAC
EMERGO GROUP | Vice President of Regulatory Affairs