Annual regulatory symposium on blood safety and supply

Over 160 registrants participated in the TGA's Annual Regulatory Symposium on Blood Safety and Supply held in Melbourne on 19 August 2002. This year's event was organised jointly by the TGA and the Paul Ehrlich Institute, which provided a distinguished and senior delegation for the seminar. These included the President of the PEI Professor Johanness Lower, the Head of the Transfusion Medicine Division Professor Rainer Seitz, the Head of the Virology Division Dr Micha Nuebling and the Head of the Blood Components Section Dr Margherite Heiden.

TGA and PEI speakers addressed various aspects of blood supply and safety, including issues around donor selection, viral testing, leucocyte reduction, GMP and in vitro diagnostics. The Director of the FDA's Office of Blood Research and Review also participated in the event and gave a detailed overview of the FDA's regulatory processes involving blood safety.

Feedback regarding the Seminar was very positive and we intend to continue doing this event every year.

A moment of relaxation following TGA's annual symposium on Blood Safety and Supply.
Left to right : Dr Albert Farrugia, Senior Advisor Blood and Tissues, Mr Terry Slater, TGA National Manager, Dr Jay Epstein, Director, FDA Office of Blood Research and Review, Professor Johannes Lower, President, Paul Ehrlich Institute

International visitors and training

From 4 to 15 November 2002 the TGA, along with the Uppsala Monitoring Centre (UMC), Sweden, are co-hosting a training course at the TGA in Canberra, with the support of the WHO. This is the first time the course, Pharmacovigilance - the Study of Adverse Drug Reactions, has been held in the southern hemisphere. Representatives from over sixteen countries are attending, and the interest has been so strong that there is a waiting list of more than thirty interested people. The Drug Information Association (DIA) has offered a number of Fellowships to allow regulatory authorities in the region to send a sponsored participant. In addition, a number of places were specifically reserved for industry representatives.

In early August 2002, a delegation led by Dr Clarence Tan, CEO, Health Sciences Authority (HSA), Singapore, visited the TGA for several days. A wide range of cooperation activities were discussed as a follow-on from the Memorandum of Intention of Cooperation on the regulation of medicines and medical devices signed by the TGA and the HSA earlier this year.

In early September 2002, Mr Anthony Chan, Chief Pharmacist, Pharmaceutical Services, Hong Kong, visited the TGA and participated in a cost-recovered GMP training program together with a senior GMP inspector of the organisation.

Under the Memorandum of Understanding with Papua New Guinea, the TGA provided a one-week training program on medicine regulation and registration for the PNG Department of Health in October 2002. The World Health Organization sponsored the program.

Over the past few months the TGA has received a number of other overseas visitors and has provided training in a variety of areas for participants from Hong Kong, Indonesia, Papua New Guinea, Singapore and Thailand. Sponsors of these activities were the World Health Organization, AusAID or other international organisations.

Rotation of the GHTF Chair and Secretariat from Australia to Japan

Currently, the Chair of the Global Harmonization Task Force (GHTF) is shared jointly in the Asia-Pacific region by Australia and Japan. The TGA held the Chair from 1 January 2001 to 30 June 2002. Japan's Ministry for Health, Labor and Welfare (MHLW) assumed the role of Chair on 1 July 2002 for the following 18 months.

The GHTF has made significant achievements in harmonising the international regulatory requirements for medical devices since its inception in 1992. The work done during Australia's term as Chair includes establishing the GHTF Steering Committee, hosting the 9th GHTF Conference in Singapore during May 2002, undertaking the GHTF strategic review, oversight and approval of the GHTF Study Group Work Plans and progressing GHTF training initiatives, including hosting the 2nd APEC Seminar on the Harmonization of Medical Device Regulations.

From 5 to 9 August 2002, meetings to effect the transition of the GHTF Chair and Secretariat from the TGA to the MHLW were held in Tokyo, Japan. These meetings involved officials from the TGA, the MHLW and the Japan Federation of Medical Device Manufacturers (JFMDA). A copy of the Transition Meeting Notice is available from the General Information page of the GHTF website <http://www.ghtf.org>.

Japan's first major activities as GHTF Chair will be the hosting of the 5th Steering Committee meeting from 28 to 30 October 2002, and organising the 10th GHTF Conference which will be held in Tokyo from 25 to 28 May 2003.

TGA Laboratory collaboration with Singapore HSA

Chemistry staff from the TGA Laboratories have assisted the Singapore HSA (Health Sciences Authority) to unravel the mystery of the slimming medicine that has been associated with serious adverse reactions in Singapore. The medicine, called Slim 10, which is not available in Australia, has been linked with thyroid problems and also to liver failure. According to the product label, the ingredients were herbal extracts and were not regarded as being possible causes of the adverse events. However, working with the HSA, TGAL chemists discovered that several undeclared substances were present in the product. These substances include thyroid extract, fenfluramine and nitrosofenfluramine, as well as various vitamins. Based on the laboratory findings, the HSA has recently prosecuted the importer and distributor of Slim 10.

WHO Global Training Network Course on Vaccine Regulation

The TGA, in its role as a National Regulatory Authority (NRA) and one of the accredited training centres around the world that contribute to the WHO Global Training Network, conducted a vaccine regulation training course on 23-30 October 2002. The course was held at the TGA in Canberra and aimed to provide training to staff of other NRAs and National Control Centres in the Western Pacific and South East Asian region that regulate vaccines. A total of seventeen applications were received and accepted, by WHO and the TGA, to attend the course. The applicants were from regulatory authorities in the region including Indonesia, China, India, Singapore, Thailand and the Philippines.