European EMA removes about 100 generic drugs
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European EMA removes about 100 generic drugs involving Johnson & Johnson, Sandoz, Teva, etc.
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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 may be suspected of fraud.
The issue 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.
Similar problems have occurred with trial data from several Indian CROs, including Semler Research and GVK Biosciences, previously targeted by the US FDA and European EMA.
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 similar data issues.
According to a previous FDA notice to Synchron, the regulator found the company had an abnormal and unexplained record of research that indicated that Synchron engaged in practices and processes that undermined the reliability of analytical methods.
The FDA said, “After careful review of your company’s research records, it was concluded that these practices and processes meant that you submitted falsified research data to the FDA.”
In addition to this, 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, for the benefit 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 drugs need to be recalled within their territories.
Reference source:
Europe to suspend about 100 generic drugs after uncovering data ‘irregularities’ at Indian CRO
European EMA removes about 100 generic drugs involving Johnson & Johnson, Sandoz, Teva, etc.
(source:internet, reference only)
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