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| GHTF > Meetings and Training > Conferences > 7th Meeting Outcomes > Summary |
GHTF:FD:99-14
Attendees
Mr. Robert Allen, MDA, United Kingdom
Mr. Robert Eccleston, FDA, United States
Mr. Maurice Freeman, MTC, Belgium
Dr. Jorge Garcia, TGA, Australia
Ms. Linda Horton, FDA, United States
Dr. Leonie Hunt, TGA, Australia
Dr. Elizabeth Jacobson, FDA, United States and GHTF Chair
Dr. Larry Kessler, FDA, United States
Ms. Jocelyn Kula, Health Canada, Canada
Ms. Elizabeth Pieterson, Health Canada, Canada
Mr. Joseph Putzeys, EC/EU, Belgium
Mr. Daisaku Sato, MHW, Japan
Ms. Tomiko Tawaragi, MHW, Japan
Dr. Toshiyoshi Tominaga, MHW, Japan
Issues & Outcomes
Dr. Jacobson opened the meeting by welcoming everyone and asked the participants to introduce themselves and identify their affiliations. She then briefly reviewed the agenda (copy attached) and proceeded to the first item
1. Review of Summary From 16-17 February 1999 Meeting:
Dr. Jacobson invited comments on the written summary of the inaugural meeting of the Chair's Advisory Group. This summary had been previously circulated for comment among the participants and revised. Dr. Tominaga noted that several comments offered previously by Japan MHW were not reflected in the current draft and asked that the comments be re-considered.
Dr. Jacobson also noted that sections of the meeting summary prepared by FDA which pertained to GHTF structure and procedures contained language that was too conclusory. She asked that the language be modified to reflect the fact that, while there was general consensus on various points, no final decisions were reached at the February meeting.
2. Proposed Plenary Agenda for 7th GHTF Meeting:
Dr. Jacobson reviewed the proposed agenda for the next day's plenary session and extended an opportunity for the participants to suggest changes or additions. None were offered.
3. Procedures for GHTF Endorsement of Study Group Documents:
Dr. Jacobson introduced the next agenda item by stating that a considerable number of Study Group guidance documents would be presented to the GHTF for final approval (endorsement) at the plenary session. Given that no formal procedures for document processing and approval have been adopted by the GHTF, Dr. Jacobson suggested that the past practice of general consensus be used to give closure to the various final Study Group documents. She added that, should consensus not be reached on a given document, it would be referred back to the authoring Study Group for reconsideration of the objections and comments.
Dr. Jacobson further recommended that, should consensus be reached, the GHTF Chair would sign off on each document using the cover sheet developed by FDA as a result of the discussion at the February 1999 meeting. Sign-off by the Chair would signify consensus among the members of the Task Force and simply express the commitment of the regulatory representatives to encourage adoption and implementation by their respective national governments.
In order for the GHTF Chair to formally transmit GHTF-endorsed guidance documents to national competent authorities, it was agreed that each competent authority should identify the appropriate official to whom such documents should be directed.
With general agreement on the above suggestions, discussion moved to whether the Task Force should take action document-by-document or en bloc. It was agreed that the Study Group Chairs would compartmentalize their presentations into three parts: (1) final documents ready for GHTF adoption (endorsement); (2) documents ready for advancement from the working draft to proposed document stage; and (3) new work items, changes in work program, or activities in need of reaffirmation by the Task Force. It was agreed that the GHTF Chair would "call the question" at the end of each Study Group presentation.
Further discussion resulted in agreement on the need for an interim procedure for approving (endorsing) documents that reach final status in the intervening period between plenary sessions. It was suggested, and agreed, that should a Study Group determine that a given document has undergone sufficient public review and is in a form suitable for final adoption (endorsement) by the Task Force, the Study Group Chair will forward the document to the GHTF Chair for distribution among the five principal regulatory members. In turn, each recipient of the document is responsible for disseminating the document to appropriate industry, professional and public groups for review and comment. It was also agreed that documents that reach the final stage will be submitted to the GHTF Chair at least two months prior to a scheduled plenary session for review by the Advisory Group, unless it is possible for the Task Force, through the Advisory Group, to endorse the final document during periods between plenary sessions. Any document not meeting this timetable will be considered ineligible for presentation and final action at the next regularly scheduled GHTF plenary session.
During this discussion, the need was reiterated for regional consolidation of comments to facilitate timely review and revision of Proposed Documents would also be made available on the GHTF Web site by Study Groups, as discussed at the February 1999 meeting.
Mr. Freeman, Dr. Kessler and Mr. Allen then previewed the documents ready for GHTF adoption (endorsement) in addition to those ready for advancement from the Working Draft to Proposed Document stage, as follows:
Mr. Eccleston noted that Study Group 3 will offer 3 final documents for GHTF adoption (endorsement), bringing the total number of final documents to 12.
Related generally to the subject of Study Group documents, Mr. Putzeys urged that attention be given to empowering the Task Force to determine whether specific work projects should be initiated or continued as a result of changing needs and priorities, to set work priorities based on current regulatory needs, and to engage in strategic planning in order to ensure timeliness, relevance and appropriateness of future work and policy directions of the GHTF. This recommendation was met with broad support among the members present. He viewed the lack of adequate attention to the issue of priorities as a critical weakness in the draft process document.
4. Proposed GHTF Operating Procedures and Ad Hoc Working Group Proposal
Dr. Jacobson introduced this subject by noting the comments received on the document initially developed by the FDA and preliminarily reviewed at the February 1999 Advisory Group meeting. She acknowledged the continuing differences of view, chiefly over regional versus national membership and the degree of formality and specificity of the proposed procedures. The Chair also recognized the existence of a document offered by the European Union and the expressed interest by Japan MHW to offer its own proposal.
Mr. Putzeys stated that the European proposal, in outline form, was not necessarily a formal European position and that a disclaimer should be added before the document is made publicly available at the GHTF plenary session and/or the GHTF Web site. (Mr. Freeman subsequently prepared a written disclaimer and, following clearance from Mr. Putzeys, provided it to Mr. Eccleston for inclusion in a covering sheet.)
Dr. Jacobson recommended that discussion of specific proposals relating to operating procedures be tabeled at the plenary session and instead be focused on reaching agreement on the establishment of an ad hoc working group with equal representation from government and industry from the five principal members. It was noted that Ms. Pieterson has volunteered to chair this group in an ex officio capacity as an extension of her GHTF chairmanship role, and that the group be charged to evaluate all relevant proposals and develop a consensus document for presentation at the next GHTF plenary session. A decision was deferred on whether a Vice- or Co-Chair is needed. Otherwise, general consensus was reached on all of the above proposals.
Additional suggestions were offered and agreed to, i.e., that Ms. Pieterson elicit nominations during the plenary session, that meetings of the ad hoc working group be open, and that interested parties be permitted to observe the proceedings. Ms. Pieterson stated her desire to convene the initial meeting of the ad hoc working group as early as September of this year.
5. GHTF-ISO TC-210 Memorandum of Understanding
Dr. Jacobson updated that Advisory Group on the progress of the document since the February 1999 meeting at which conceptual agreement on the working agreement (in the form of a Memorandum of Understanding) was reached. She reported that TC-210 unanimously adopted a resolution at its April 1999 meeting in Turkey supporting the agreement in principle and substance.
Agreement was reached among the Advisory Group members that the MoU should be presented as is at the 7th plenary session with an enthusiastic call for its adoption and an understanding that the ISO Secretary-General is expected to sign the agreement following sign-off by Dr. Jacobson and Mr. Allen in his capacity as Chair of ISO/TC 210.
6. Date/Location of 8th GHTF Meeting
As host of the next GHTF meeting, Ms. Pieterson proposed that the 8th session be held in the latter half of September 2000. There were no objections.
7. MHW Presentation on Regulation of Tissue-Based Products
The meeting concluded with a presentation by the representatives from Japan MHW regarding harmonization of international regulation of tissue-engineered products and the Ministry's plan to propose that the International Conference on Harmonization (ICH) take the lead in sorting out issues relating to regulatory coverage, definitions and other relevant matters.
Adjournment
Following general discussion of the MHW presentation, and with no other business pending, Dr. Jacobson adjourned the second meeting of the Chair's Advisory Group.
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Attachment - Meeting Agenda
A G E N D A
GHTF Chair's Advisory Group
9:00 a.m.-12:00 p.m. -- Monday, 28 June 1999
Conference Room D
1. Acceptability of ad hoc working group concept and proposed terms of reference
2. Role of industry and observers
3. Nominations procedure: Chair (Co- or Vice-Chair)/Members
Updated 16 November 2004
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