1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
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The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework.
The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness / performance and quality of medical devices, promoting technological innovation and facilitating international trade, and the primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices. These documents, which are developed by five (5) different GHTF Study Groups, can then be adopted/implemented by member national regulatory authorities. The relationships between the work of each Study Group can be represented schematically.
The GHTF also serves as an information exchange forum through which countries with medical device regulatory systems under development can benefit from the experience of those with existing systems and/or pattern their practices upon those of GHTF founding members.
The idea for an international partnership between medical device regulatory authorities and the regulated industry, one that would aim to achieve harmonisation in medical device regulatory practices, was conceived in 1992. In September of that year, senior regulatory officials and industry representatives from the European Union, the United States of America, Canada and Japan met in Nice, France to explore the feasibility of forming such a global consultative partnership aimed at harmonising medical device regulatory practices.
These talks would develop into a working framework put forth by the representatives of the European Commission two months later, and would lead to the inaugural meeting of the organisation now known as the Global Harmonization Task Force (hereinafter referred to as the GHTF), in January 1993.
The first priority of the GHTF was to establish three "study groups" and charge each one with the task of examining a discrete aspect of medical device regulation.
Study Group 1 was asked to compare the operations of each member nation's regulatory program. Study Group 2 was assigned the task of reviewing the Good Manufacturing Practice (GMP) requirements and methodologies used by national regulatory bodies, and Study Group 3 was directed to evaluate existing quality design systems and develop a guidance document that reflected the optimal features of each.
During the second meeting of the GHTF, held in Tokyo, Japan, in November 1993, representatives from Australia joined the organisation and Study Group 4 was founded to develop guidance on harmonised regulatory auditing practices. In addition, participants from the member states of the European Free Trade Area (EFTA), the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC), the International Organisation for Standardisation (ISO), and the World Health Organisation (WHO) were present.
In June 1994, the GHTF met for a third time in Montreal, Canada. At this meeting, Study Group 1's activities were redefined as the identification of regulatory aspects that would lend themselves to harmonisation, in particular, those relating to the safety and efficacy/performance of medical devices.
At the next meeting, held in Vancouver, Canada, in June 1995, the GHTF determined that it needed to broaden its focus to encompass a review of current adverse incident reporting and post-marketing surveillance requirements, with the intent being to examine the possibility of harmonising data collection and adverse event reporting systems, thereby enhancing worldwide public health.
To accommodate this new activity, the responsibilities of the existing Study Group 2 were consolidated with those of Study Group 3 and a new Study Group 2 was established. In addition, the GHTF assigned Study Group 1 with the task of developing a standardised format for pre-market submissions and to determine the similarities and differences between each country's product labelling requirements.
At its October 1996 meeting in Lisbon, Portugal, the GHTF gave preliminary consideration to the concept of forming a "steering committee" as a means of developing and standardising procedures for managing Task Force activities.
In February 1998, the GHTF held its sixth Conference in Sydney, Australia. At that Conference, several preliminary Study Group documents were presented as being ready for dissemination for comment and/or publication, and these included documents addressing the following topics:
a) essential principles of safety and performance of medical devices on a global basis;
b) the role of standards in the assessment of medical devices;
c) comparison of device adverse reporting systems in the European Union, United States, Japan, Canada and Australia;
d) the management of information related to medical device vigilance reporting;
e) adverse event reporting rules for device manufacturers, including minimum data sets for manufacturer reporting to competent authorities;
f) design control guidance for medical devices; and
g) guidelines for regulatory auditing of quality systems of medical device manufacturers.
However, because no procedures for consultation or document approval had been established to date, it was decided that these documents could not be distributed any further and that the development of such procedures would be the next task of the organisation.
At that same meeting, it was also decided that chairmanship of the organisation would be transferred from Europe to North America for three years commencing in February 1998, after which rotation would continue between Australia and Japan and then on to Europe.
Under the auspices of their role as Chair, representatives of the United States then volunteered to draft a set of practices and procedures encompassing document development and distribution.
The Task Force also agreed to pursue a formal liaison relationship with ISO/TC 210, the ISO Technical Committee responsible for Quality Management and Corresponding General Aspects for Medical Devices, and whose focus is to ensure the harmonisation of quality system standards.
At the 7th GHTF Conference in Bethesda, Maryland, a set of draft principles and procedures was presented to the general membership and although it was extremely comprehensive, the document was also seen as too prescriptive for an organisation in its developmental phase. It was proposed and agreed to that during Canada's term as Chair, an ad hoc committee would be established with the goal of developing guiding principles and operating procedures for the organisation. The ad hoc committee was also authorised to act as an advisory body to the GHTF Chair, for the purposes of ensuring document progression until a governance model was in place.
In September 1999, chairmanship of the GHTF passed to Canada.
September 1999 - December 2000
The Ad Hoc Procedures Group, as the ad hoc committee came to be called, held its inaugural meeting in October 1999 in Ottawa, Canada. At that meeting, members worked on three draft documents entitled "Guiding Principles", "Roles and Responsibilities" and "Operating Procedures", each designed to scope out an important aspect of GHTF activity.
Besides ensuring a way for GHTF Study Group outputs to be formalised and distributed to those who could use them, work on these documents was also important because it was recognised that in order for the organisation to move forward, a governance model and clear responsibilities for all those involved in GHTF deliberations needed to be established. It was also felt that this in turn, would ensure that the similar but independent interests of the regulatory and industry representatives involved would be preserved and that the organisation's outputs would also be further legitimised.
At the second meeting of the Ad Hoc Procedures Group, held in February 2000 in Santa Clara, California, work on the three draft documents progressed and it was agreed that the documents could be posted for all members to see and provide comment on prior to the 8th GHTF Conference, scheduled for 18-22 September 2000.
The 8th GHTF Conference was the largest GHTF gathering to date with over 200 representatives from over 30 countries in attendance. In addition to endorsing three additional Study Group documents, the Conference also saw the acceptance of the three draft procedural documents.
It was also agreed that as its first priority, the newly formed GHTF Steering Committee, as would be established according to the "Roles and Responsibilities" document, would undertake a strategic review of its accomplishments and objectives.
On 1 January 2001, chairmanship of the GHTF passed to Australia.
In accordance with the "GHTF Roles and Responsibilities" document, transition meetings involving officials from Health Canada's Medical Devices Bureau and Australia's Therapeutic Goods Administration (TGA) took place in Canberra, Australia during March 2001.
Immediately prior to this, Australia hosted the inaugural meeting of the GHTF Steering Committee in Sydney, Australia from 28 February - 2 March 2001. The Steering Committee is the GHTF's governing body responsible for management oversight and policy setting for the organisation, and replaces the Ad Hoc Procedures Group established under the US FDA's Chairmanship.
The Committee met on three further occasions through May of 2002 and some of its major work initiatives have included -
The 9th GHTF Conference was originally scheduled to be held in Barcelona, Spain during October 2001, but was subsequently postponed due to the 11 September 2001 terrorist attacks in the United States.
With the unanimous agreement of the Steering Committee, the TGA re-scheduled the event and in conjunction with Singapore's Health Sciences Authority (HSA), co-hosted a highly successful 9th GHTF Conference in Singapore from 12 - 16 May 2002. The two agencies also co-hosted an equally successful GHTF training event, the 2nd APEC Seminar on the Harmonization of Medical Device Regulations, from 17 - 18 May 2002.
Both events were heavily attended and the Conference was the largest GHTF gathering to date, with 220 delegates representing 29 countries. 180 delegates attended the APEC Seminar - primarily regulators and industry representatives from countries with developing regulatory systems, including 41 regulators and 59 industry representatives from Latin American and Asian Countries.
All Delegates to the Conference benefited from an exciting and interactive program, the major highlight being the one and a half day GHTF Plenary which included individual Sessions on the Global Regulatory Model, New and Emerging Technologies and The Total Product Life Cycle: A Focus on Postmarket Surveillance and Vigilance.
Topics discussed during the APEC Seminar included an overview of the GHTF, a presentation on the global medical device market and regulatory harmonization, and presentations by Members of the four GHTF Study Groups on Quality Systems and Auditing requirements, Postmarket Surveillance requirements and the harmonized approaches to medical device registration, classification and approval.
The dedicated efforts made by Members of the GHTF Steering Committee and Study Groups, representing Australia, Japan, Europe, USA and Canada were a significant contributing factor to the success of the events.
On 1 July 2002, chairmanship of the GHTF passed to Japan.
In accordance with the "GHTF Roles and Responsibilities" document, transition meetings to transfer the GHTF Chair and Secretariat from Australia's Therapeutic Goods Administration (TGA) to Japan's Ministry for Health, Labour and Welfare (MHLW) were held in Tokyo, Japan on 5 to 9 August 2002. These meetings involved officials from the TGA, the MHLW, the Japan Federation of Medical Device Manufacturers (JFMDA) and secretaries.
The GHTF Steering Committee held its 5th meeting in Tokyo, Japan on 28 to 30 October 2002 and its 6th meeting in San Francisco, USA on 5 to 7 November 2003. The major work initiatives included:
The 10th GHTF Conference was originally scheduled to be held in Tokyo, Japan during May 2003. However, it was cancelled due to the outbreak of SARS. The sixth meeting of the GHTF Steering Committee meeting and meetings of four Study Groups, scheduled in parallel with the Conference, were postponed as well.
Despite the cancellation of these events, there were significant achievements in GHTF activities owing to the dedicated efforts made by Members of the GHTF Steering Committee and Study Groups.
On 1 January 2004, chairmanship of the GHTF passed to the European Commission.
In accordance with the "GHTF Roles and Responsibilities" document, transition meetings to transfer the GHTF Chair and Secretariat from Japan's Ministry of Health, Labour and Welfare (MHLW) to the European Commission (EC) were held in Brussels, Belgium from 26 to 28 January 2004. These meetings involved officials from the MHLW, the EC, the Japan Federation of Medical Device Manufacturers (JFMDA), the European Confederation of Medical Suppliers Association (EUCOMED) and secretaries.
The 7th Meeting of the GHTF Steering Committee will be held in Paris, France in June 2004.
Updated 20 November 2007
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