ARPANSA - establishing a new regulatory agency

It has been almost 12 months since it was decided to establish a new Agency, the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), to regulate radiation protection and nuclear safety for Commonwealth places and undertakings. The new Agency will be headed by a statutory office holder and will combine the resources of the Australian Radiation Laboratory (ARL) in Melbourne and the Nuclear Safety Bureau (NSB) in Sydney.

The Australian Radiation Protection and Nuclear Safety (ARPANS) Bill 1998 and Regulations to underpin the legislation have been drafted. The Bill has been passed by the House of Representatives and is now awaiting debate in the Senate when Parliament resumes.

The ARPANSA Taskforce has been established to oversee and co-ordinate the establishment of the new Agency. The Taskforce is working closely with staff at the ARL and the NSB. The Taskforce is located in Canberra and can be contacted on (02) 6281 7642.

Laboratories news

Labs articles of interest in this issue include a new appointment in blood regulation, the move of the Medical Device Incident Reporting Scheme to TGAL and Pharmaceutical Benefits Listing cutoff dates for sample testing. Articles start on p10 <http://www.tga.gov.au/docs/html/tganews/news27/lab.htm>.

Laurayne Bowler to head review of poisons and scheduling legisation

Laurayne Bowler presents an award at a recent Branch function

It was recently announced that Laurayne Bowler, acting Director of Chemicals and Non-prescription Drug Branch would head a review of the National Drugs and Poisons Scheduling legislation. During Laurayne's 18 month period as acting Director, many changes have been implemented including the establishment of the Complementary Medicines Evaluation Committee. Laurayne has facilitated these changes through actively working towards establishing a mutually constructive relationship with the complementary and proprietary medicine sectors of industry. Laurayne's hard-working efforts have been appreciated and all TGA staff wish her well in her new position.

Medicines in Pregnancy handbook

Work has commenced on revising and updating the popular Medicines in Pregnancy Handbook 3rd Edition which was published in 1996. Further details on p6 <http://www.tga.gov.au/docs/html/tganews/news27/dseb.htm>.

New schedule of TGA fees and charges

A new schedule of TGA Fees and Charges was distributed to sponsors and other interested parties in July. Further copies may be obtained from the TGA Publications Office ph 1800 020 653 or fax 02 6232 8605.

Regulatory guide released

The new version of the Australian Medical Device Requirements under the Therapeutic Goods Act 1989 version 4 ("DR4") has been released. The publication is available through the TGA Publications Office at $120 for one copy, $80 for each subsequent copy, $25 per copy for overseas airmail.

Revised breast implant booklet released

A revised version of the Breast Implant Information Booklet, which provides an up-to-date guide to enable women to make careful and informed decisions about whether to undergo breast implant surgery, has just been released by the TGA.

The Breast Implant Information Booklet will provide women with a balanced view of the risks and benefits of breast implants. The booklet, first published in 1995, clarifies many of the issues raised at the outset of the silicone gel controversy.

Full story on p12 <http://www.tga.gov.au/docs/html/tganews/news27/cab.htm>.

TGA publications

There is a large variety of TGA publications. Those available to the public can be found in the TGA Publications List available from the TGA Publications Office (1800 020 653 or 02 6232 8610) and on our Internet site. Most publications are available from this Office, but a number (especially TGA Acts and Regulations) are only available from Government Info Shops.

Apart from TGA News the TGA also publishes the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm>, the Australian Therapeutic Device Bulletin <http://www.tga.gov.au/docs/html/atdb/tdbindex.htm>, the GMP Newsletter, the Laboratory Information Bulletin <http://www.tga.gov.au/docs/html/lib/libindex.htm> (all free) and Australian Recalls and Cancellations ($60.00 per year).