www.fdanews.com/articles/177322-ema-to-launch-review-of-products-from-pharmaceutics-international
EMA to Launch Review of Products from Pharmaceutics International
June 30, 2016
Hunt Valley, Md.-based Pharmaceutics International has found itself in the crosshairs of another European regulator, with the European Medicines Agency launching a review of the company’s drugs.
The review comes in response to a February 2016 inspection by the UK’s Medicines and Healthcare products Regulatory Agency that uncovered several GMP violations. The inspection resulted in MHRA ordering Pharmaceutics International to recall its drug batches, suspend clinical trials and cease distribution.
The EMA’s Committee for Medicinal Products for Human Use will conduct the review of the inspection findings on the products’ overall benefits and risks.