Regulatory Relations


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-05-01-2009
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The U.S.–EU Transatlantic Administrative Simplication Plan continues on the road of development.

Leaders from both sides of the Atlantic shared the stage in late March to provide DIA EuroMeeting attendees with an update on the U.S.-EU Transatlantic Administrative Simplification Plan. Speaking on behalf of their agencies were Thomas Lönngren, executive director of EMEA, and Murray Lumpkin, MD, FDA's deputy commissioner for international programs.

FDA's Dr. Murray Lumpkin described the transatlantic initiative as a "relationship that began in earnest 10 years ago."

From the sound of things, it's smooth waters for the Transatlantic plan, which is taking the relationship to the next level. This summer, as part of an employee exchange program, FDA will send one staff member to London to set up office at EMEA headquarters. The two-year, permanent position was awarded to Janice Soreth, MD, deputy director, medical products, Europe/OIP/FDA.

Soreth's EU counterpart, who will head to the American capital, has not been selected yet. Lönngren joked that a decision would be made once the giant package of rules on his chair was read, eventually predicting this autumn as the earliest EMEA would get the ball rolling.

Amidst humor, he made his feelings clear about the exchange, calling it a "milestone, where we are bringing two agencies together."

Wide Array of Shared Interests

The amiable Lumpkin expressed excitement over the upcoming employee transplants. But no sooner did he take the podium than he told the audience he wanted them to walk away aware that both agencies have "quite extensive" relationships beyond the Transatlantic plan. "[It's] a very important one," he said, "but in reality, we have relationships at a process level that go on at a daily basis and go on at the technical level as well"—and these relationships, according to his calculations, result in 1000s of document exchanges every year.

Nonetheless, Lumpkin admits nowadays it's hard to imagine not working with the EU on a business level with the Transatlantic plan, which requires both sides follow two rules in their quest for simplification. They cannot take on projects that reduce public health protection or projects that require any changes to legislation.

Pharma's take

What they have taken on so far does please pharma, says Ali Harrison, vice president of European regulatory affairs at AstraZeneca, who provided a personal perspective from industry on the U.S.-EU simplification plan.

Industry is extremely supportive of all activities, Harrison told the audience, and interested in dialogue. "This is a great forum to share information," she said, referring to DIA, "but we'd like to see more engagement."

Personally, she would also like to see—"just suggestions"—projects in pediatric applications, risk management plans, and patient reported outcomes (PROs). "Anything that simplifies things is welcome," Harrison said, adding that "it would be great if one set of responses would be sufficient for both agencies."

In the meantime, both sides say they will continue to figure out ways to take the relationship further in their transatlantic endeavor to improve public health through simplification.—Kerri Nelen

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