IMDRF Working With ICH on Harmonized Electronic Submission System for Drugs, Devices

Posted 25 March 2013 | By

US Food and Drug Administration (FDA) regulator Kim Trautman, associate director of international affairs at the Center for Devices and Radiological Health (CDRH), told an audience of regulatory officials last week that medical device harmonization efforts spearheaded by the new International Medical Device Regulators' Forum (IMDRF) are on pace and expected to yield new cooperation between the drug and device sectors in the coming months.


IMDRF launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), which disbanded in December 2012 after its device regulatory members decided to split off and form their own juncture without the involvement of industry. At present, organizations involved in the IMDRF include the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's National Health Surveillance Agency (ANVISA), Health Canada, the European Union (EU), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and the Asian Harmonization Working Party (AHWP).

Other regulatory bodies, including those of Russia and the World Health Organization (WHO), are in the process of exploring membership. Another, China, is expected to join the organization as a formal member shortly. "Just recently we have gotten positive word that China is going to become a member of the IMDRF management committee," Tratuman said at a joint conference put on by FDA and the Association for the Advancement of Medical instrumentation (AAMI), an industry trade group, on 21 March 2013.

But since the GHTF's dismantling, industry has found itself in something of an unusual position-on the outside looking in, and with more than a few concerns. Perhaps the two most frequent concerns raised by industry groups: What will become of the GHTF's existing workload, and what comes next?

The former of those two questions was answered in October 2012 at the 2012 RAPS Regulatory Convergence, where regulators said IMDRF has every intent of maintaining GHTF's workload and existing documents going forward.

"We are committed to update GHTF documents where necessary," CDRH's Jacqueline Minor said.

Trautman's Update

But looking forward, Trautman said there is much for the medical device industry to anticipate coming out of IMDRF.

No longer is the focus of global regulators just on regulatory harmonization, Trautman said. Instead, they're increasingly looking to a "regulatory convergence" in which additional parts of the regulatory ecosystem-the technical documents, standards, practices and scientific principles among them-are voluntarily adopted by multiple countries.

"The process of convergence represents an important form of regulatory cooperation which in turn makes possible additional, enhanced forms of cooperation and collaboration between regulatory authorities," Trautman explained.

And while other groups have dug into making system-wide changes, Trautman said IMDRF is focused more on short-term, 12- to 18-month changes that can benefit the regulatory ecosystem more immediately.

And that quicker turnaround time could stand to benefit industry as regulators address perceived problems more quickly instead of batting around draft proposals for years on end.

UDI System: Too Late to Make a Difference?

Case in point may well be the global Unique Device Identification (UDI) system, Tratuman said. That effort has been historically complicated by several regulators' attempts to put together their own systems, which have been in the works for the better part of a decade.

Trautman said the IMDRF is now focused on trying to publish that regulation by the end of 2013-a remarkably fast turnaround for an agency that will barely be a year old if that schedule holds true.

But one of the largest challenges facing IMDRF's UDI rule may be the existence of other pending UDI rules. Trautman observed that FDA published its own draft regulation for a UDI system in 2012, and is now planning to release that rule in the summer of 2013-just months before the IMDRF's proposed rule is supposed to be published.

She conceded that these overlapping timelines aren't preferable from the perspective of the IMDRF. "It really isn't going to help any particular regulator if we can't exchange that information with our regulatory counterparts throughout the world," she said. Right now, Trautman said IMDRF is "honing in" on a handful of difficult issues that she said are holding up global implementation of a unified UDI system, including software kits and "four or five" other unspecified issues.

A draft report on this issue is due to be presented to the IMDRF management committee at the 19 March 2013 meeting in France. If that document is accepted, it would be available for comment over the summer of 2013, with the goal of getting a rule published by the end of 2013, Tratuman explained.

The NCAR System

Trautman said another of the largest items under IMDRF review is the National Competent Authority Reporting (NCAR) System, first established and used under GHTF to communicate recalls and vigilance reporting.

"We're taking a look at this NCAR system to see if there are adjustments that can be made," she said, adding that they're particularly focused on fine-tuning their understanding of risk and looking at reporting that goes on in the current system to determine what information is exchanged, and what might stand to be added in the future.

The IMDRF working group in charge of this assessment has already developed a preliminary report to be presented at the 19 March 2013 IMDRF meeting in France, Trautman added. Those recommendations were not available at the time of this article's publication.

Medical Devices and Drugs: An Upcoming Union of Electronic Submissions?

Trautman also said that IMDRF working groups are working on a draft table of contents that would constitute the backbone of a so-called "Regulated Product Submission" (RPS) standard, a sort of electronic common technical document (eCTD) that could then be used to make a single submission that is recognizable by multiple regulatory authorities.

She added that they hope to have a document (for non-IVD medical devices) out for comment in May/June 2013. The table of contents for the IVD subgroup should be published in late 2013, Trautman speculated.

Other IMDRF subgroups are working closely with the Health Level 7 organization to develop an "envelope" for electronic product submissions, and Trautman said their efforts may have a wide-ranging impact.

Trautman explained that the IMDRF group is trying to "marry" a similar RPS effort under development by the International Conference on Harmonization (ICH)-a pharmaceutical-focused harmonization group. "Clearly, if we're going to be working on electronic submissions to any one of our particular agencies, we are looking to have a coordinated effort between our different sister commodities such as drugs, devices, biologics and so forth," Trautman said.

This could, in theory, make it much easier for a combination drug-device product to be submitted to multiple agencies around the world.

Tratuman said she anticipated a pilot program will be launched during the summer of 2013.


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