GHTF Organisational Structure

The original concept behind the formation of the Global Harmonization Task Force (GHTF) was to bring together experienced regulators and industry members on a regular basis in order to discuss ways in which medical device regulatory practices within their jurisdictions could be harmonized. As such, the Study Groups charged with examining discrete aspects of medical device regulation were established without the auspices of a "formal" organizing committee. In later years, it was decided that chairmanship of the organization would rotate between the five founding members and that meetings would be hosted in varying locations around the world, largely in an attempt to ease the financial burden of any one group always having to travel long distances.

The Chair's Advisory Group was the first attempt at establishing a body charged with providing strategic direction to those involved in GHTF activities. This committee, which was established in 1998 by Dr. Bruce Burlington of the United States Food and Drug Administration (FDA), during his term as Chair, met twice in 1999, and was responsible for initiating the concept of ensuring transparency and promoting progress in the organization's work. The Chair's Advisory Group was also responsible for initiating work on a set of basic principles of operation and an organizational structure for the Task Force.

Although the FDA-drafted document entitled Guiding Principles and Operating Procedures was included as an agenda item at the Chair's Advisory Group Meeting of the 7th GHTF Meeting (June, 1999 in Bethesda, Maryland), no consensus was reached on its acceptability. In addition, following comments from industry members, who had been at the table since 1992 but had not been involved in drafting the Guiding Principles and Operating Procedures document because the Chair's Advisory Group included only regulatory representatives; the GHTF Chair, Dr. Elizabeth Jacobson, called for the establishment of a joint industry and regulator ad hoc working group. This group, which would consist of one industry and one regulatory representative from each founding member would be charged with evaluating all relevant proposals, reconciling differences and developing a consensus document for consideration by the GHTF at their next plenary meeting. The Ad Hoc Procedures Working Group (as it came to be called) would also examine and make recommendations regarding guidance document development and endorsement and in certain cases, act as an advisory body to the GHTF Chair.

In early August 2000, the Ad Hoc Procedures Group posted three draft procedural documents on the GHTF website for comment. The documents, "Guiding Principles", Roles and Responsibilities" and "Operating Procedures" propose among other things, the creation of a governing body for the organization, defined responsibilities for those involved in GHTF activities and clear procedures for document development and approval.

At the Plenary Session of the 8th GHTF Conference (21 September 2000), the three procedural documents were presented by Members of the Ad Hoc Procedures Group (AHPG) and accepted by all GHTF Members. The GHTF Chair (Ms Beth Pieterson from Health Canada) subsequently proceeded with establishing the membership of the new GHTF Steering Committee which replaced the AHPG.

Ms Rita Maclachlan of Australia's Therapeutic Goods Administration (the new GHTF Chair as at 1 January 2001) hosted the inaugural meeting of the GHTF Steering Committee in Sydney, Australia, from 28 February - 2 March 2001. As specified by the procedural document, "GHTF Roles and Responsibilities", the Steering Committee was then the governing body responsible for management oversight and policy setting for the GHTF.