Global Harmonization Task Force

The 10th Global Harmonization Task Force (GHTF) conference Total Solution for Human Health Care will be held on 25-28 May 2003 in Tokyo, Japan.

The TGA formally handed over the GHTF Chairmanship to the Japanese Ministry of Health and Welfare in July 2002.

Australia's period as chair was very successful with the achievement and progression of a number of important initiatives including:

• implementation of the GHTF Governance arrangements
• undertaking the GHTF strategic review
• hosting the 9th GHTF Conference in Singapore
• hosting the 2nd APEC Seminar on the harmonisation of medical devices regulations.

International training

Over the past few months the TGA has welcomed visitors, many of whom hold senior executive level positions, from Indonesia, Malaysia, China, Singapore, Japan, Fiji, Thailand, Sri Lanka, the Philippines, Vietnam and the Czech Republic, and has provided training programs sponsored by the WHO, AusAID, the DIA and the respective overseas regulatory agencies. One such program, presented in Singapore in November 2002, was for staff involved in the GMP function.

The TGA International Training Calendar for 2003 has now been finalised. This is a major initiative designed to assist the TGA to better manage the increasing demand for relevant training in the regulation of therapeutic products, particularly from the various regulatory agencies in the Asia Pacific region. All training activities are carried out on a full cost recovery basis and more information about the training calendar <http://www.tga.gov.au/international/inttrain.htm> can be found on this website.

PIC/S Expert Circle on Inspection of Computerised Systems

The TGA hosted the 2nd meeting of the PIC/S (Pharmaceutical Inspection Cooperation Scheme) Expert Circle on Inspection of Computerised Systems in Canberra on 17 and 18 February 2003. Australia has been a member of PIC/S since 1993.

A total of thirty-six GMP inspectors from seventeen different countries attended the meeting. All of the inspectors are actively involved in the inspection of computerised systems. The meeting discussed emerging trends in the area of computerised systems, and training was provided in inspection procedures and techniques.

The opportunity was taken to review comments from industry on the PIC/S guidance document Good Practice for Computerised Systems in 'GXP' Regulated Environments. This document is available from the PIC/S website <http://www.picscheme.org>.

Regional Regulators' Forum - Tokyo

The 2nd Asia Pacific Regional Regulators' Forum was held on 15 November 2002 in Tokyo, Japan, in conjunction with the World Self Medication Industry 14th General Assembly and 5th Asia Pacific Regional Conference. Japan's Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau convened the Forum, with the TGA being invited to co-chair the Forum. The Forum followed on from the success of the 1st Regulators' Forum, hosted by the TGA in Sydney in 2000.

The Forum welcomed the return of many of the Asia Pacific regulators who attended the 1st Forum, with the addition of a representative from Vietnam. Attendance at the Tokyo Forum demonstrated the significance of regional cooperation and collaboration between regulators, recognising the need for common understanding of the many global issues faced by regulators.

Discussions between regulators included:

• new technologies and the use of internet technology for access to medicines and medicines information
• the harmonisation of terminology
• the possibility of developing broad collaborative guidelines between regional regulators.

Regulators also presented on recent initiatives undertaken in their country on the regulation of medicines and a Declaration was developed. The declaration built on the Sydney 2000 declaration and emphasised the importance and mutual benefits to public health and safety through the sharing of information and collaboration on the regulation of medicines. All of the regulators at the Forum endorsed the "Tokyo Declaration 2002 A Shared Vision".

The Tokyo Declaration can be found on the Trans Tasman Therapeutic Products Agency website <http://www.anztpa.org/regional/2002tokyo.htm>.

TGA blood safety expert chairs international policy group

Dr Albert Farrugia, acting Head of the Blood and Tissues Group, Office of Devices, Blood and Tissues, TGA, has been appointed as the Chair of the Global Collaboration for Blood Safety, a WHO-sponsored coalition of experts in blood safety and related matters. The Policy Group is one of three working groups constituting the Collaboration. It is tasked with developing good policy practices and information sharing in the areas of blood safety and management.