EMA calls for suspension of generic drugs after concerns about quality of data
A list of generic drugs — including 41 that are available in the UK — have been recommended for suspension across the EU because of doubts over the quality of the bioequivalence data used to grant their national marketing authorisation.
The European Medicines Agency, the EU’s drug safety watchdog, has published a list of recommended products for suspension on its website.
The medicines were all granted a national marketing authorisation partly based on the results of studies carried out by Micro Therapeutic Research Labs, a contract research organisation based in India.
But, in a review prompted by concerns expressed by drugs safety authorities in Austria and the Netherlands in February 2016, the EMA found the bioequivalence data from those studies to be unreliable.
In a statement issued on 24 March 2017, the EMA said: “The suspensions can be lifted once alternative data establishing bioequivalence are provided.”
Other products in the process of being marketed that rely on data from the same company have also been suspended until further notice.
However, the agency has told individual drug safety authorities in the EU — including the UK’s Medicines and Healthcare products Regulatory Agency — that if a medicine is critical and there is no alternative product, the drug can remain available to patients while new data are generated.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202520
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