FDA to Tighten Inspection Standards for Overseas Clinical Trials Amid Surge in China

The U.S. Food and Drug Administration (FDA) will tighten its standards for on-site inspections of overseas clinical trial sites.

According to U.S. biopharmaceutical news outlet BioSpace on the 2nd (local time), four senior FDA officials announced plans to expand oversight of overseas clinical trial sites in an editorial published that day in FDA Voices.

The editorial, titled 'Good Clinical Practice (GCP) Is Not Optional,' said the FDA plans to strengthen oversight of overseas clinical trial sites, improve communication with drugmakers and expand training for internal reviewers. The editorial did not name any specific country.

An FDA official said it was important to "create a level playing field so that there is neither a perception nor a reality that moving research outside the United States allows companies to cut corners."

The FDA expressed particular concern about early feasibility studies and Phase 1 research conducted in "countries or regions where geopolitical circumstances make it difficult to obtain informed consent or raise human rights concerns."

The agency also said it would communicate proactively with sponsors before submissions and discuss the origins of overseas clinical data and the status of investigational new drug (IND) applications and investigational device exemption (IDE) applications early in development.

A senior FDA official said, "We have definitely increased the number of Bioresearch Monitoring (BIMO) investigators in our China office and several other global offices."

The move comes amid a surge in clinical trials in China. According to an April report from the National Bureau of Economic Research (NBER), China accounted for less than 8% of clinical trials worldwide in 2010 but surpassed the United States in annual trial registrations in 2020.

Reps. John Moolenaar (R-Mich.) and Ben Cline (R-Va.) said in a letter last month to acting FDA Commissioner Kyle Diamantas that "accepting clinical data from China could pose real risks to patients."

At the end of the editorial, the FDA warned drugmakers: "If you are considering building a regulatory strategy on clinical data obtained at sites the FDA could not inspect or under circumstances that raise serious questions about the ethical conditions of the research, think again."