Global Harmonization Task Force Moves Into "Implementation Mode"
From the September 17, 2007, issue of "The Gray Sheet"
Efforts to harmonize device regulations globally will see more activity over the next year if Larry Kessler has his way.
Kessler, who is director of CDRH's Office of Science and Engineering Laboratories, is in a position to make it happen. In January, he was appointed to an 18-month post as chairman of the Global Harmonization Task Force.
Founded in 1992 by device regulators and industry reps from the United States, Canada, Europe, Japan and Australia to facilitate trade, GHTF has spent much of the past 15 years engaging in meetings and cyclical comment periods to build consensus on a collection of guidance documents.
The result: 26 1finalized documents on topics ranging from premarket product assessment to manufacturing standard oversight to adverse event reporting.
The group, however, has not put the necessary effort into the next required step - making sure each country is actually implementing the guidances, according to Kessler. That is where his attention will be over the next year, the GHTF head told "The Gray Sheet" in a Sept. 10 interview.
Walking The Walk On Global Device Regulation
"The focus over the next year is rather than 'talking the talk,' we need to 'walk the walk,'" Kessler said.
"Rather than just being passive and putting documents out and saying to the world 'we hope you read them and like them,' we are actually going to be doing a lot of significant work implementing [the] documents as well as outreach to other countries."
In May, GHTF issued an 2action plan signaling its intention to "move from a consensus-building mode to an implementation mode." And in a couple of weeks, at the 11th GHTF meeting scheduled for Oct. 3-4 in Washington, D.C., the task force will take more steps in this direction. In particular, three presentations will be made that are particularly important to this transition, according to Kessler.
Tim Ulatowski, who heads CDRH's Office of Compliance, will present findings from a GHTF steering committee analysis of precisely which guidances have been implemented by which of the five founding member governments and where there are gaps.
It is the first time this information will be available in a comprehensive format, Kessler said. "It is really going to be a way to look at ourselves and say 'here is where we have made progress and here is where progress has yet to be made,'" he explained. "And I think that comes with the recognition of parties having to make commitments about doing something about it."
Also at the meeting, former GHTF officials and other international regulators led by former director of Health Canada's Medical Devices Bureau Beth Pieterson will present a draft version of a "retrospective assessment" of the task force's operations during the past 15 years.
The report, based on interviews and other research, is expected to provide independent advice about how GHTF can improve its operations to have a larger impact on international regulations (see chart).
And with regulators participating in the assessment from Latin America and Southeast Asia - areas not included in the core GHTF membership - it will offer critiques on how well the task force is completing its full mission, as described by Kessler - "not only to harmonize the regulations of the five founding members, but also to serve as a model for changing regulatory systems around the world."
To further that goal, a third important component of the upcoming meeting will be the release of a training plan that the task force will use to more actively communicate its guidelines to different countries.
The GHTF training program will be implemented during a two-day session in Latin America later in October and another one in the spring in Malaysia.
Harmonization Results To Date: A "Real Mix"
All of this activity does not suggest that the results of harmonization efforts until now have been insubstantial. "Things are actually changing worldwide and GHTF has been a real engine for this," Kessler said.
He cites Australia as by far the most successful of the GHTF members in applying the harmonized guidances. That country's Therapeutic Goods Administration was required by 2002 3legislation to reform its entire device regulatory system, giving it an opening to incorporate many of the GHTF guidelines in its rules.
Another bright spot is the 4Association of Southeast Asian Nations, representing ten countries in the region including Indonesia, Thailand and Malaysia, which have committed their nations' health departments to rewriting medical device regulations by 2012 based on GHTF guidelines.
But overall, Kessler admits, harmonization "is a real mix across the world," leaving unnecessary obstacles to market access for industry.
"If you are industry and you want to know whether if you do something one way, it will be accepted worldwide, [you will find] there are still some significant variations - whether it's compliance or premarket submissions or postmarket monitoring."
To get the ball rolling in response to gaps in harmonization that will be highlighted at the upcoming meeting, Ulatowski also will announce eight guidance documents that CDRH plans to revise in the near term with the explicit goal of moving closer to GHTF recommendations.
FDA compliance with all GHTF guidelines would still require "a mix of guidance, regulation and legislation," Kessler acknowledged. But he maintains that a lot can be accomplished simply with guidances - the easiest of the three to enact.
While the FDA staffer declined to specifically identify the eight CDRH guidance documents slated for near-term revision, and Ulatowski did not respond to a request for comment, Kessler suggested that FDA's move would be a model for other international agencies to follow.
Expanded Industry Participation Is A Goal
Kessler also hopes to spark expanded industry action in support of harmonization. "In certain areas, they have not held up their end of the bargain," Kessler asserted.
Specifically, he referred to efforts to allow manufacturers the opportunity to be subject to inspections that satisfy multiple international authorities at once.
The accredited persons inspection program, established in 2002, allows companies to hire selected third parties to fulfill FDA quality system audit requirements as well manufacturing standard requirements for Europe, Canada and other countries; however, that program has languished primarily due to lack of industry interest (5"The Gray Sheet" Oct. 23, 2006, p. 14).
Last year, FDA and Health Canada formed the similar Pilot Multipurpose Audit Program (PMAP), allowing a single inspection to fulfill U.S. and Canada requirements, but again there was limited participation from industry. Companies say they are concerned with the potential for too much overlap between what they see as very different relationships with FDA, which they tend to view as having more of a policing function, and accredited persons, which serve something closer to a consulting function.
Kessler says the agency will be looking to expand PMAP next year and has already sent leaders to U.S. firms offering a two-in-one FDA/Canada inspection. He says industry needs to "come to the table and play" to match their rhetoric supporting harmonization.
"The regulators have not been perfect either," he stressed. "I am not pointing a single finger one way. But here is an opportunity for industry to play constructively and we are going to challenge them."
- David Filmore
CLICK HERE to sign up for a free trial of "The Gray Sheet"
