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Faked trial data allegations will lead to EU-wide debate on standards - generics body

Country : India

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by Richard Staines
LONDON, Dec 9 (APM) - Europe’s generic trade body on Tuesday said the EU investigation into potentially faked clinical data from an Indian research firm will lead to a new debate on clinical trial standards.
In an emailed interview, European Generic Medicines Association director general, Adrian van den Hoven, told APM that because of the investigation into India’s GVK-Biosciences, the issue of oversight into clinical trial quality will have to be revisited.
Van den Hoven made his comments after some EU member states began suspending marketing authorisations for 25 generic medicines that had been approved using data from GVK. (APMMA 40720)
When asked whether this and other cases would lead to companies using EU contract research organisations (CROs) over countries such as India, van den Hoven noted that GVK was one of hundreds such organisations in countless countries.
Clinical and laboratory standards in the hundreds of CROs operating across the world are upheld by audits from pharma companies and inspections from EU regulators, he added.

Strict regulation beneficial

He said: “Long term, we see strict regulation as ultimately beneficial for the industry as this should reinforce the standards for conducting clinical trials.
“This is why our industry wants to engage more closely in future with regulators to strengthen cooperation regarding industry audits and regulatory inspections in this field. Strong good clinical and laboratory practice is in the best long term interest of an industry that serves patients.
“In the future, the EGA anticipates the need for a renewed dialogue with the European Medicines Agency, (mutual recognition and decentralised procedure specialists), and EU member states on the oversight of the (Good Clinical Practice) and (Good Laboratory Compliance) compliance for clinical trials.”
In the short term, he said the suspended marketing authorisations would have obvious financial implications for the companies affected.

Reassure patients

When asked if the perception of the industry had been damaged, Van den Hoven said the EGA was "assessing the potential impact" of the investigation into GVK Biosciences.
He added that EGA member companies were considering "pre-emptive measures" to ensure patient safety in "cooperation with regulators", although he provided no further details.
Van den Hoven noted in the interview that no evidence has emerged to indicate patient safety has been put at risk.
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