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New Foreign Drug Trial Rule Coming

By Sheri Qualters
July 31, 2008

A new U.S. Food and Drug Administration final rule governing clinical trials held in foreign countries will spark painstaking legal review of pharmaceutical companies' protocols for trials. Although the FDA lacks authority to police clinical trials in other countries, it can and does regulate the types of clinical trial data it requires and accepts from companies applying for new drug approval or marketing approval for a drug or biological product.

The upshot is that pharmaceutical companies will need lawyers' help to design foreign trials to meet U.S. standards if they ever hope to sell drugs tested in those trials in the United States. The new rule, which takes effect on Oct. 27, standardizes the requirements across countries and adds requirements for trials in many countries, lawyers say.

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