Full article reprinted from "The Gray Sheet" - July 13, 2009
Japan has already hired 12 of the 13 new device reviewers it pledged to add by year end, bringing its total to 47 as of April, according to a July 6 report. U.S. device industry reps are pleased. Find out more...
Japan has already hired 12 of the 13 new device reviewers it pledged to add by year end, bringing its total to 47 as of April, according to a July 6 report. U.S. device industry reps are pleased.
AdvaMed, which lobbied for the increase, expected the hiring would be gradual. The speed is "extremely encouraging," said Philip Agress, AdvaMed's VP for global strategy and analysis. "It shows that they're taking the action program very seriously and they're moving quickly to implement the measures."
Under the so-called action program, implemented April 1, Japan pledged to triple the number of device reviewers in five years and to make significant reforms to regulatory requirements in return for more user fee revenue (1 'The Gray Sheet' July 14, 2008).
The July 6 report is an update on the U.S.-Japan Regulatory Reform and Competition Policy Initiative, a forum for the two governments to agree on policies to stimulate open markets. It was presented to President Obama and Japanese Prime Minister Taro Aso.
The report, which includes updates relevant to several industries, also specified Japan's intent to "ensure knowledgeable and skillful" device reviewers with training programs that promote personnel exchanges between domestic and foreign universities and by referencing the U.S. FDA's training programs.
The bilateral document also includes incremental updates on other device action program reforms.
Japan's government says it has organized task force discussions between regulators and industry about the appropriate review for modifications of already approved devices. Manufacturers complain that they often need to submit full-blown new-product applications even for minor modifications in Japan, but the government has agreed to refine the requirements.
The U.S.-Japan report also states that Japan is working on a question-and-answer document to clarify when a company can rely on accelerated stability test data rather than real-time stability assessment.
The government is also developing a plan to allow certain devices to be bundled into a single application and to streamline raw material submissions.
- Ingrid Mezo
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