GHTF Has Acted; Now Industry Must
Global harmonization is no longer a buzzword, but a reality. The Global Harmonization Task Force (GHTF) has developed a number of guidance documents, and many of them are starting to be implemented. GHTF chairman Larry Kessler, who is also director of CDRH’s Office of Science and Engineering Laboratories, took some time with MD&DI to assess the GHTF’s progress. His thoughts appear as a Q&A in our January issue.
There are now systems that enable nations with developed regulatory systems to share audits and adverse event reports, and to accept certain kinds of premarket applications from the same form. In turn, these systems could well be adopted by nations with less-developed regulatory systems, so they don’t have to start from scratch. This is a remarkable achievement, because for years it was unclear just how eager the regulators around the world were for true harmonization.
But Kessler is not content for the GHTF to sit on its laurels. In his comments to MD&DI, he identifies some areas that need work. In particular, he is concerned about industry’s commitment. “I believe industry has not come to the table in terms of submitting [applications in the Summary Technical Documentation format] and volunteering for multipurpose audits,” he said. “They have not used the opportunities that some regulators have provided, and that makes moving forward with harmonization difficult.”
So now it’s up to you, industry, to take this process to the next level. If there are concerns that potential effects of harmonization could be bad for business, now is the time to air them. If there is an unwillingness to take advantage of what has been put in place so far, now is the time to explain why. Otherwise, the harmonization effort could be derailed, or implemented in a way industry doesn’t want. And there is too much at stake for that to happen.
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