ADEC recommendations now on the TGA web site

ADEC recommendations for approval and recommendations on matters of safety have been published in the Government gazette routinely since 1992. These recommendations are now being posted on the TGA Web site under the heading Australian Drug Evaluation Committee <http://www.tga.gov.au/docs/html/adec/adecrecs.htm>. All 1998 ADEC gazette notices to date have been posted to the site. Recommendations are usually gazetted within 3-4 weeks of the Meeting and will now appear on the site at the same time as gazettal.

Australian Statistics on Medicines 1997

The "Australian Statistics on Medicines 1997" just published by the Drug Utilisation Sub-committee (DUSC) of the Pharmaceutical Benefits Advisory Committee is now available for purchase through Government Information Shops.

Changes to manufacturer details for registered and export-only drugs

Sponsors of registered and export-only drugs are reminded that changes to manufacturer details are required to be notified to the TGA so that the Australian Register of Therapeutic Goods (ARTG) records can be updated for affected goods. To ensure that these changes can be processed smoothly, it is necessary that sponsors clearly identify the changes they are making and provide the information required. Sponsors of Australian listed drugs are required to submit a full ELF application showing the updated manufacturer details.

Changes to sterility test regulations

On December 1 1998 the TGA adopted the BP 1998. At the same time TGO 11 Standard for Sterile Therapeutic Goods was revoked and replaced by Therapeutic Goods Order Number 63 for medical devices. TGO 63 determines that the BP/EP 98 sterility test "shall constitute the standard for therapeutic devices that are labelled as sterile or sterilised or otherwise purport to be sterile or sterilised". Further details on p8 <http://www.tga.gov.au/docs/html/tganews/news28/lab.htm>.

New advertising arrangements and the Therapeutic Goods Advertising Code

Following a request from the industry, the Regulations to the Therapeutic Goods Act 1989 were amended on 24 December 1997 (Statutory Rules No. 400 of 1997), subsequent to the disbanding of the Media Council of Australia (MCA). These amendments established a new Therapeutic Goods Advertising Code Council (TGACC) which is representative of the community at large. The TGACC aims to achieve greater uniformity in advertising approval processes and standards relating to both print and electronic broadcast media.

Amendments to the Regulations also resulted in the establishment of a Complaints Resolution Panel (CRP), which receives and considers complaints about advertisements, takes appropriate action and makes recommendations to the Secretary/TGA where necessary.

In addition, the Regulations establish an approval scheme for advertisements for medicines intended for publication or insertion in the mainstream print media.

Further details on p10 <http://www.tga.gov.au/docs/html/tganews/news28/cab.htm>.

TGA publications

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

Update on the Mutual Recognition Agreement (MRA) between Australia & the European Community (EC)

The Therapeutic Goods Administration (TGA) has been advised that the Intergovernmental Agreement between the Commonwealth and States/Territories has now been finalised and Australia and the EC have exchanged notes. It is anticipated that the MRA will come into effect on 1 January 1999.

Vietnamese visit

Professor Le Van Truyen, Vice-Minister of Health, Ministry of Health, Vietnam, visited the TGA on Tuesday 29 September 1998. The Vice-Minister was accompanied by the Deputy Director General of The Drug Administration of Vietnam, Mr Tran Cong Ky. Both Professor Truyen and the TGA National Manager Mr Terry Slater have indicated their strong support for the program of joint collaboration that has recently been agreed between the Drug Administration of Vietnam and TGA, and which is outlined in a Memorandum of Understanding signed by the two government regulatory agencies in June 1998.

L to R: Dr. Roger Bateman, Mr. Terry Slater, Professor Le Van Truyen, Vice Minister of Health, Vietnam.