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Marketing approval for antibiotic reportedly withdrawn by MHRA

MHRA reported to have concerns over integrity of clinical trial data

Drug testing

7 July 2016

Reuters News Agency has reported that the UK healthcare regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) has suspended marketing approval for an antibiotic that had been cleared for use based on clinical trials run by India’s Quest Life Sciences.

The MHRA is said to have concerns over the integrity of the trial data.  

The decision will prevent the sale of a generic version of erythromycin that is sold in the UK by Dawa Ltd, a Kenyan drug maker.

Other pending drug approval requests that have relied on data supplied by Quest could be affected by this development.

Reuters report that the MHRA has said that it is in touch with the affected parties who have the right to appeal and to submit new data. Quest is believed to be planning to appeal against the decision.

Yati Chugh, president of Quest, told Reuters that Quest had significantly improved its quality systems since 2014, and would ask the MHRA to re-inspect its site, as MHRA’s move means four other drugs Quest performed trials on that are awaiting approval with the UK regulator will not be approved until the agency clears its facility.

In June 2015 the World Health Organisation contacted Quest with concerns about deviations from the WHO Good Clinical Practices and Good Laboratory Practices standards, and issued a Notice of Concern over data manipulation of ECG data by the company.

An MHRA spokesman said “The MHRA inspectors identified a large number of issues which indicated that there were very serious concerns with many aspects of the company’s quality system,” adding the problems cast “serious doubt on the integrity of any data produced.”

Clinical trials lawyer Gene Matthews, said:

“It is extremely important that clinical trial data is robust and reliable, and that regulatory authorities are able to act quickly to publish their concerns when discrepancies arise.

“In a global economy it is critical that patients in all parts of the world can trust that the drugs they are taking are safe for use, no matter where the clinical trials that underpin their authorisation for human use takes place.”

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