International meetings

Counterfeit medicines

Dr Larry Kelly, TGAL's acting Director, attended the Forum on Counterfeit Medicines in Arizona, USA, from 8 to 11 November 2004. The forum, organised by the US FDA, meets every six months and consists of laboratory-based scientists from regulatory agencies worldwide including the USA, Canada, the UK, Germany, the Netherlands, Singapore, Switzerland and Australia. The meetings usually focus on discussions on the development of analytical procedures used to detect counterfeit active pharmaceutical ingredients, counterfeit dosage forms and toxic compounds in nutritional supplements as well as sources of toxic herbals.

EDQM international conference & symposium

The European Directorate for the Quality of Medicines (EDQM), Council of Europe, organised an International Conference and Symposium in Budapest, Hungary, from 3 to 7 October 2004. The conference marked the 40th anniversary of the European Pharmacopoeia. Plenary sessions covered the roles and views of the various European regulatory authorities and industry groups and looked at opportunities for international harmonisation with the American and Japanese Pharmacopoeias and cooperation with the WHO. There were also a series of concurrent workshops covering a wide range of issues. The TGA representative participated in workshops on the Biological Standardisation programme, Blood/Plasma products, and International Harmonisation and Cell and Gene therapy products.

The second meeting was a symposium on Serological Potency Testing for Diphtheria and other vaccines. This meeting was called to discuss the findings of the international collaborative study on this new test. The TGA was a participant in this study. The meeting resolved to recommend incorporation of this test for Diphtheria and Tetanus vaccines into the new edition of the European Pharmacopoeia. Further studies are planned to test if sera from the same group of animals can be used for testing of other components of multivalent vaccines.

International visitors & training

Over the past few months, the TGA has hosted a number of short-term visits by delegations from regulatory agencies in Indonesia, China and South Korea.

The TGA also provided training programs on a cost recovery basis or with financial sponsorship from AusAID in the areas of vaccine quality assurance, OTC medicine regulation, medical device regulation and GMP on medicinal products for government officials from Indonesia, Hong Kong, Malaysia, Singapore and Macau.

For the second time, the "WHO-UMC @ TGA Pharmacovigilance Training Course" is to be held at the TGA. The course is presented in conjunction with the WHO Centre for International Drug Monitoring, Uppsala, Sweden. It will run from 8 to 19 November with more than twenty participants from various overseas regulatory agencies and Australian industry organisations. The teaching faculty comprises Australian experts and staff from both Uppsala and the TGA.

Vaccine regulation training

The TGA Laboratories will be conducting the fourth World Health Organization (WHO) Global Training Network Course (GTN) on vaccine regulation for national control authorities. The course will be run over six days from 24 November to 1 December 2004.

The purpose of the GTN course is to provide training, through interactive workshops, to those countries that require assistance in strengthening their regulation, manufacture and quality control of vaccines. Seventeen participants representing national regulatory authorities and national control laboratories from nine countries will be participating, including China, the Philippines, Vietnam, Nigeria, Egypt and the Ukraine. This year there will also be two representatives attending the course from the WHO regional offices of South East Asia and Africa.

Quality of anti-retroviral medicines

The World Health Organization (WHO) has run a Pilot Procurement Quality and Sourcing Project, which assesses the acceptability in principle of HIV/AIDS drugs for purchase by UN agencies. However, a large number of problems and deficiencies in the quality of anti-retroviral medicines (ARVs) have been identified during the operation of this program. To address this, the WHO approached the TGA Laboratories (TGAL) to seek participation in a work program designed to provide quality control specifications for use by all WHO member states, particularly those in developing regions. The request recognises TGAL's capabilities and reputation in the area of pharmaceutical analysis. The cost of the work will be met by the WHO.

TGAL agreed to be one of five international laboratories to participate in this project. The main objective of the project was to develop robust test methods and specifications for the family of ARVs that are currently available in international commerce. Specifically, TGAL was asked to contribute to the development of draft monographs for three ARVs, namely: lamivudine, stavudine and zidovudine. TGAL contributed by corroborating some work already done by other laboratories and proposing new assay methods employing simple techniques such as UV spectroscopy. This work is complete and the three monographs have been submitted to the WHO, who will circulate them for comment.