Committee to examine the use of the term "drug free"

Following a public campaign and discussion in parliament, a special committee has been established to examine the use of the term "drug free" in advertising of therapeutic goods.

The committee, which comprises industry, consumer and health professional representatives, will report to the Parliamentary Secretary by 8 May 1998. The report will be tabled in parliament and the Government will respond to the recommendations of the committee.

The next edition of TGA News will contain further information on this issue.

Launch of TGA Coprorate Plan and Customer Service Charter

The Parliamentary Secretary, the Hon. Trish Worth MP, launched the TGA Corporate Plan and the TGA Customer Service Charter on Thursday 9 April 1998.

This issue of TGA News includes a copy of TGA's Customer Service Charter.

"This charter... makes public our commitment to deliver high quality service to our customers and specifies the standards for service delivery..." Ms Worth said at the launch.

If you would like additional copies of the charter or a copy of the Corporate Plan, please contact the Publications Office on 1800 020 653.

ELF 2 software release

The new version of the Electronic Lodgement Facility (ELF) software, known as ELF 2, has been released.

ELF 2 has several enhancements that improve the speed and functionality of the existing system. It is more user friendly and has an extended help system to guide users through the listing drug application process.

Revised drug/device distinction document

A number of recent changes in policy, primarily related to disinfectants and in vitro diagnostic goods (IVDGs), have required revisions of the Drug & Device Distinction document. The document provides guidance as to how the TGA classifies certain therapeutic goods that are not readily identified as drugs or devices. In the revision, the USA FDA and European Union classifications were examined to ensure consistency with international practices. The revisions will assist sponsors to determine which area of the TGA has primary responsibility for assessing data submitted in support of applications for entry on the Australian Register of Therapeutic Goods (ARTG).

Top of page

Medical Devices Task Force update

The backlog of applications for listing of medical devices on the Australian Register of Therapeutic Goods has been cleared by the Task Force. Established in November 1997 the seven member Task Force cleared the backlog before Christmas. This impressive achievement has been acknowledged in many letters to the TGA from industry.

The Task Force is currently processing applications in less than the agreed 30 day turned around time. In addition, it is helping develop a Device Electronic Application Listing Facility for listable medical devices.

DR4 available soon

The new version of the Australian Medical Device Requirements under the Therapeutic Goods Act 1989 (Version 4 - 'DR4') will be available soon. It guides sponsors on the information required in support of an application for listing or registration of therapeutic devices on the Australian Register of Therapeutic Goods (ARTG).

DR4 replaces the previous edition "Requirements for the Supply of Therapeutic Devices under the Therapeutic Goods Act 1989 (DR3)" published in September 1993. Since then there have been numerous changes to TGA policy and the legislation, creating the need to consolidate these changes in a single document.

The publication of DR4 follows an extended period of development and consultation with industry and other interested parties. The document of some 600 pages has four parts:

• Introduction
• Registrable Devices
• Listable Devices
• Appendices

The parts have pre-punched inserts for ring binders and may be ordered from the TGA Publications Office. Sponsors should purchase copies of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations from Government Info Shops to use in conjunction with DR4.

Technological advances, the Mutual Recognition Agreement with the European Union and the move towards global harmonisation should lead to future revisions of DR4. These will be available through the Internet.

Increase in cost recovery

As part of its overall 1997-98 Budget strategy, the Government increased the level of cost recovery from industry for the regulation of therapeutic goods to 100% from 1998-99.

At the same time the TGA has been working with industry, health professionals, State and Territory departments of health, consumer groups and other stakeholders implementing a range of reforms flowing from the Government's response to the 1996 independent review of the TGA. Significant progress has been made towards full implementation.

The TGA is reviewing its fees and charges for 1998-99 in consultation with industry associations. A copy of the revised schedule, to apply from 1 July 1998, will be sent to all subscribers in late May or early June 1998.

Over the next few years the TGA will continue to develop a world class regulatory system for therapeutic products which also takes account of community attitudes and expectations about self-medication and the role of preventive and complementary medicines.

A new era in sterility testing: the end of unique Australian requirements

At their November 1997 meeting, the Therapeutic Goods Committee accepted the proposal that the TGA adopt the BP/EP harmonised Test for Sterility in lieu of Therapeutic Goods Order Number 11, with a revised Appendix C to be retained as a guideline document. The revised Appendix C, renamed TGA Guidelines on Sterility Testing of Therapeutic Goods <http://www.tga.gov.au/docs/html/sterilit.htm> to indicate its new role as a stand-alone guidance document, is intended to assist companies by providing the practical details that the BP/EP Test for Sterility lacks.

Full story on page 8. <http://www.tga.gov.au/docs/html/tganews/news26/lab.htm>

Microbial limits for non-sterile pharmaceuticals

The need to retain Australian regulatory requirements for non-sterile pharmaceutical products has been under discussion since publication of guideline limits in the 1996 Addendum to the British Pharmacopoeia (BP).

The April and November 1997 meetings of the Therapeutic Goods Committee (TGC) considered submissions from the Microbiology Section of TGA Laboratories and comment from industry on revised TGAL Guidelines for Assessing the Results of Microbiological Tests on Non-sterile Pharmaceuticals for Human Use. The TGC also considered the current international situation, and the pharmacopoeial proposals for international harmonisation of microbial limits.

As a result, the TGC has recommended retention, for the present, of the current TGAL Guidelines, ratified by TGC in 1994 and updated in 1995 to include a new category for herbal teas. The situation will be further reviewed within two years, pending the outcome of the harmonisation process.

Full story on page 8 <http://www.tga.gov.au/docs/html/tganews/news26/lab.htm>.