Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello community,

In a leadership meeting today one of the leaders asked; if we held a clinical trial as a requirement for an FDA submission and then we wanted to apply to the EU.  Would we need to run the trial with EU samples as well?

Thanks!

Hello Anon,

It depends on the device type, the patient population, user population, etc., so it is not a yes or no answer.  In many cases, regulatory agencies do accept clinical trial/investigation data from different countries with rationales and reasoning for why these clinical data from other countries would be acceptable.  Some devices there would not be a problem, but if there are devices which are used differently by the user in various countries, the regulators might view this negatively.  The short answer is you might be able to use clinical data from the United States in the European Union, but might want to seek some further expert advice.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 17-Jan-2023 19:18
From: Anonymous Member
Subject: Clinical Trial specimen requirement

This message was posted by a user wishing to remain anonymous

Hello community,

In a leadership meeting today one of the leaders asked; if we held a clinical trial as a requirement for an FDA submission and then we wanted to apply to the EU.  Would we need to run the trial with EU samples as well?

Thanks!

This message was posted by a user wishing to remain anonymous


In addition to what Richard has provided, prevalence of the disease is another number you need to research and compare with the one you had used for your patient/subject size calculation. These numbers vary from one country to another, even more so from one region to another. You should also ensure to follow the guidance / ISO documents pertinent to each jurisdiction.
Original Message:
Sent: 17-Jan-2023 19:18
From: Anonymous Member
Subject: Clinical Trial specimen requirement

This message was posted by a user wishing to remain anonymous

Hello community,

In a leadership meeting today one of the leaders asked; if we held a clinical trial as a requirement for an FDA submission and then we wanted to apply to the EU.  Would we need to run the trial with EU samples as well?

Thanks!