Full article reprinted from "The Gray Sheet" - December 22, 2008
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Find out how U.S. device manufacturers hope an "action program" adopted by the Japanese government Dec. 17 and tied to increased industry user fees will significantly speed device approval times there. |
Full article reprinted from "The Gray Sheet" - December 22, 2008
U.S. companies have long complained of major inefficiencies in getting new products on the Japanese market; goading Japan's regulators to streamline the process has been one of AdvaMed's top international priorities.
Since July, industry representatives have engaged in intensive negotiations with the Japanese government to push for reforms (1"The Gray Sheet" July 14, 2008, p. 3). They now say their purpose has been achieved.
"The action program is fairly comprehensive, and it covers almost all of the major areas that have created unnecessary delays in the approval process," said Phil Agress, AdvaMed's VP for global strategy and analysis, who took part in the talks.
Device Reviewers Will Triple In Five Years
Japanese regulators agreed to increase the number of medical device reviewers during the next five years from 35 to 104 and to make significant reforms to regulatory requirements.
The changes will be made in return for more user fee revenue. The fee rates will increase from current levels by a factor of 1.2 to 2.8, depending on the category of product, Agress explained in an interview.
The largest fee increase would impact new medical devices in Class IV, the highest-risk category in Japan, Agress said. Lower-risk devices would see more moderate fee hikes.
A specific user fee schedule will be released later this month.
Japan plans to increase the number of reviewers on an annual basis in roughly equal increments, adding 13 in fiscal 2009 and 14 in each of the remaining four years, Agress said.
The plan, which takes effect April 1, 2009, also calls for objective performance measures that will be used to evaluate the reviewers semi-annually.
"They will be publicly accountable, so we'll be able to see whether the benefits that all of these measures are intended to produce actually accrue or not," he said.
Reforms: 3-Track Review, Less Human Data
As the ranks of reviewers rise, Japan will also be taking steps to streamline requirements, according to AdvaMed.
As part of the five-year plan, the government will allow all low-risk Class II products to be approved via a third party, similar to notified bodies used in the European Union. Currently, only a portion of Class II products can go through the third-party process.
Further, for products that will continue to require review by the Pharmaceutical and Medical Devices Agency (PMDA), Japan will establish three tracks, one for completely new products, one for improved products and one for "me-too" products, with separate reviewers specializing in each track, Agress said.
The hope is that having separate cadres of reviewers "will lead to greater efficiencies through better knowledge of the different requirements for each of the tracks," he explained.
Also as part of the reforms, Japan will reconsider clinical data requirements, allowing a greater portion of products on the market without pre-market human testing, moving closer to the U.S. threshold for when clinical trials are necessary.
A major sticking point between industry and Japanese regulators in the past has focused on situations when companies want to make relatively minor changes to a device or its labeling.
Industry complains that regulators have expected a complete review process no matter what the request, going down to even a change in a facility address.
Under the action program, "partial" device change, or supplement, requirements will be more based on risk, with some changes only mandating that a company notify regulators. Some very basic changes may not even require that, Agress suggested.
Even under the new approach, though, companies will still have to consult with reviewers, who will decide whether the new, less stringent requirements apply to a particular change on a case-by-case basis.
The program also provides more clarity about when companies can employ accelerated rather than more drawn-out product stability tests as part of the approval process.
PMDA regulators in practice almost universally require manufacturers to prove a device component is stable for a specified period of time by evaluating it for that specified interval. In the U.S. and other countries, equations are often relied upon to validate that a shorter testing period under certain conditions appropriately simulates longer-term stability evaluation. Japan is now beginning to designate more clearly when it will allow use of such techniques.
Implementation, Inspections Next Focus
Now that these commitments are on paper, the next step is putting them into practice.
"The Action Program is a good start toward bringing Japan's approval procedures and review times closer to those in the United States and Europe, and we look forward to working with Japanese regulators to implement the program effectively for the benefit of Japanese patients," stated Stephen Ubl, president and CEO of AdvaMed.
There are also several other areas where industry would like to see improvements at some point, Agress said.
PMDA's Quality Management System review for facilities overseas is currently product specific, he explained. Instead, industry would like such inspections to be conducted for the entire factory "and all the products that come out of that factory so they don't have to keep going back to the same facility for different products."
Also, Agress said, industry wants Japan to simplify its factory accreditation process.
- Ingrid Mezo
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