update - US FDA declines to comment on potential investigation

EMA says CRO monitoring activity not location based

By Gareth Macdonald contact

- Last updated on GMT

iStock/AdrianHancu
iStock/AdrianHancu

Related tags: Food and drug administration, European medicines agency

The EMA has stressed its monitoring of CROs is location independent after raising concerns about third Indian contractor in two years.

The currently London-based​ European Medicines Agency (EMA) recommended the suspension of 331 drugs tested by Chennai, India-based contract research organisation (CRO) Micro Therapeutic Research Labs on Monday​.

The agency – which began investigating the Micro in December​ – said it made the recommendation after determining that the results of bioequivalence studies conducted by the CRO at two sites were unreliable.

An agency spokeswoman told us “These sites were inspected by the Austrian and Dutch authorities and the inspections identified several concerns regarding misrepresentation of study data and deficiencies in documentation and data handling​.”

Indian CROs

The recommendation follows less than two years after the EMA said drugs tested by GVK Biosciences​ should be pulled from the market as a result of concerns about validity of data from studies conducted at its site in Hyderabad. The European Commission followed the advice in July 2015​.

More recently​ the EMA recommended the suspension of drugs whose approval relied on bioequivalence data generated by Bangalore based Semler Research Centre. Again the agency said it had discovered evidence of data manipulation and called on drug firms to re-do studies.

The recommendation was adopted in September​.

Investigation

The EMA declined to say if it is investigating any other Indian CROs.

The spokeswoman told us “the Agency and the Member States carefully monitor the CROs that are used in marketing authorisation applications independently of where they are located.”

She added that: “The system in place includes an annual routine CRO inspection programme of the CROs most used in marketing authorisation applications and regular exchange of information with international regulators​.”

Update

The US Food and Drug Administration (FDA) told us it "does not discuss pending or potential enforcement actions except with the firms and individuals who are the subject of those actions" when we asked if it planned to investigate Micro.

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