What Happens After Global Harmonization Goes Kaput?

Taking over many of its roles, Trautman said, will be the new International Medical Device Regulators Forum, which held its first meeting in Singapore, at the end of February 2012. It is a voluntary group of regulators meant to “accelerate international medical regulatory harmonization and convergence.”

One of the key differences is that the membership will be regulators only, unlike GHTF, which included regulators and industry. A goal of the new group is for regulatory requirements and approaches across countries and regions to become more similar, “as a result of the adoption of the same technical documents, standards and scientific principles (harmonization) and similar regulatory practices and procedures.”

The GHTF was successful, Trautman said, in establishing one set of good manufacturing practices so that various nations’ GMPs were close to identical, although FDA and other nations’ agencies did have additional requirements. Asserting that it is time for some fundamental changes, however, Trautman said sometimes there are issues that are written into law and that was an area “where some of the issues were starting to get stuck in GHTF.”

Many of the regulators in the founding GHTF countries believe that “We have basically developed a regulatory framework through GHTF guidance documents for emerging regulators, but we need to start stepping up to the plate and really start converging on some of our practices,” Trautman said.

A model for the new group, she said, is the Pharmaceutical International Conference on Harmonization (ICH), where regulators agree on the work items at the highest level of the respective agencies. Although the topics might not be as big as some tackled in GHTF, she said, the convergence may be vital. In the ICH, “They said they really needed and valued the time that regulators had to sit down and talk regulator to regulator, and not have to worry about sensitive information, private information, and so forth.”

Trautman stressed that, although FDA is one of the largest regulatory agencies, it can’t regulate the world, performing inspections of the 9000 medical device manufacturers registered with the agency. “So we have to find ways not to duplicate” and find ways regulators can leverage off of each other,” she said. In addition, there was a complaint over the years in GHTF as to how industry representatives were chosen, because sometimes it was the larger associations that had the money for the travel involved in participating.

She did add, however, that under the new IMDRF, working groups will be set up to involve other stakeholders including industry, physicians, and other institutions. Various work efforts may include regulators-only, industry-only, or a mixture.
Nations at the first meeting were Australia, Brazil, Canada, Europe, Japan and the United States, with observers from China, the Russian Federation and the World Health Organization. China, she said, is working actively on getting approval from its government to become a full member at the management committee level. It was also a positive sign that Russia came to the table, she said, and the World Health Organization is playing a big role.

The Asian Harmonization Working Party is invited as an affiliate, she noted. Its chairperson, who is always a regulator or a government representative from AHWP, can observe at the management committee meetings. That’s important, she indicated, because AHWP is a strong consortium of countries that have less mature systems and that are actually in various areas beyond Asia. The Asian-Pacific Economic Cooperation also is an observer.

One goal the group has in the near future is reviewing the GHTF National Competent Authority Report Exchange Program which was set up to exchange postmarketing safety information on medical devices with global distribution. Trautman said the system had been helpful in Europe. For the United States, however, one difficulty is this country must have formal confidentiality arrangements with the prospective governments in order to share confidential information. The GHTF documents will be maintained through the IMDRF.

Trautman also told the group it is likely to hear more about product registries in light of problems with metal-on-metal hip implants and breast implants. But, she added tha, for the most part, “globally, the governments do not have the authority to go ahead and go full force with registries.”

But also in terms of registries, she said, “We really need, as an industry, to look at who can we partner with, because the regulators, the industry, we can’t fund everything. The doctors, the hospitals and the institutions, they need to step up and play in this game, too, from a global perspective.”

Background and other documents on the new group are at: www.imdrf.org.