European EMA Removes About 100 Generic Drugs Involving Johnson & Johnson, Sandoz, Teva, etc.

A few days ago, the European Medicines Agency (EMA) recommended that European countries suspend the use of about 100 generic drugs.

The European EMA said in a statement that up to 100 generic drugs were recommended to be discontinued this time, mainly because after testing a generic drug from an India-based CRO company, it found that the CRO company's trial data had integrity problems and even The potential for fraud has also raised serious concerns about the Indian company's quality management system and the reliability of data on the company's website.

Generic companies affected by the European EMA’s decision include Johnson & Johnson, Sandoz, Viatris, Teva, Jubilant, Wockhardt, Accord Healthcare, Aurora Biofarma, Strides Pharma, Tillomed Pharma, Orifarm Generics, Stada, Brillpharma, Micro Labs, ratiopharm , Bennet Pharmaceutica, Medicair Bioscience Laboratories, Pinewood, etc.

It's worth noting that Synchron Research Services, which is the subject of this outbreak, is not the first CRO company to come under the spotlight for data problems. Previously, the US FDA and European EMA had targeted several Indian CROs, including Semler Research and GVK Biosciences, with similar problems with their trial data.

As was the case with Synchron, regulators also required Semler to repeat the bioequivalence/bioavailability study at an acceptable alternative study site. And last September, Synchron also came under fire from the FDA for a similar data issue.

According to the FDA's previous notice to Synchron, the regulator found the company had an abnormal and unexplained research record that indicated that Synchron engaged in practices and processes that undermined the reliability of analytical methods. The FDA said it "concluded after careful review of your company's research records that these practices and processes meant that you submitted falsified research data to the FDA."

In addition, the European and American EMA warned member states that the drugs proposed to be suspended this time "may have crucial effects in certain EU member states", such as the lack of available alternatives. Therefore, in the interest of patients, national authorities can temporarily postpone the decision to suspend the use of the drug. In addition, Member States should also decide whether the affected medicines need to be recalled within their territories.