02 Ağustos 2016
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Dozens of generic drugs face EU banThe Pharmaceutical Journal
28 JUL 2016By Debbie Andalo
Site inspections spark concern about drug approvals based on data from Semler Research Center in Bangalore.
Dozens of generic drugs including 24 available in the UK face being banned from use across the EU because of doubts about the data collected to support their marketing approval.
The European Medicines Agency made the recommendation following a review into the quality of bioequivalence studies carried out at the Semler Research Center in Bangalore, India. The review was prompted by requests made in April 2016 to the Committee for Medicinal Products
for Human Use (CHMP) by medicines safety regulators in Denmark, Germany, the Netherlands, Spain and the UK. A list of the potentially affected drugs is available on the EMAs website
The review also followed a site inspection carried out by the US Food and Drug Administration (FDA), which identified cases where samples used in studies on the site were substituted and manipulated. The World Health Organization (WHO), whose inspectors also visited the site, had previously expressed similar concerns about the integrity of the data.
The EMA says the findings from the two international inspections call into question the quality management system in place at Semler, and therefore the reliability of any data used to support marketing authorisation of products in the EU.The agency is proposing that all medicines given EU approval based entirely on trials carried out at Semler Research Center should be suspended from use. Some products with additional data to support their use from other research sites will continue to be available (see list
The EMA will give EU states the flexibility to ignore the suspension of any medicine deemed critical for patients where there are no alternatives.The proposals, including a list of the banned and unbanned drugs, will now go to the European Commission for approval before being adopted by EU member states.
The UKs Medicines and Healthcare products Regulatory Agency (MHRA) says it was aware of the controversy surrounding the Semler Research Center and the outcome of the inspections by the FDA and the WHO.A spokesperson for the MHRA played down the EMA recommendations. There is no evidence that medicines currently on the UK market are unsafe or lack efficacy. The EMAs CHMP has reviewed the issues identified at the Semler facility and have concluded that on this occasion no recall of products is necessary, the spokesperson says.
If the recommendations are upheld by the European Commission, the MHRA says that it will be given 30 days to implement the drug suspensions.People should continue to take their medicines as prescribed. If anyone has questions about their medication they should speak to their doctor, the spokesperson advises.
Citation: The Pharmaceutical Journal, PJ July 2016 online, online | DOI: 10.1211/PJ.2016.20201500