FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA’s International Inspection Program Reports Increased Data Sharing

April 16, 2018

A European Medicines Agency report states that 944 API manufacturers were inspected in the first six years of the International Active Pharmaceutical Ingredient Inspection Program.

The agency said participating authorities conducted 1,333 unique inspections between the program’s launch in 2011 and 2016, including: 310 by EU authorities, 762 by the U.S. FDA, 130 by Australia’s Therapeutic Goods Administration, and 131 by the World Health Organization.

Of the 944 unique sites inspected, the program identified 458 “common interest” sites — of interest to at least 2 participating authorities in the program — and found they were primarily located in India and China.

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