EMA Reviewing Indian CRO Semler After FDA Warns of Data Integrity Issues

Regulatory NewsRegulatory News | 29 April 2016 |  By 

The European Medicines Agency (EMA) on Friday announced it is reviewing all EU-authorized drugs that relied on studies conducted by contract research organization (CRO) Semler Research after recent inspections uncovered serious data integrity violations at its Bangalore, India facility.

EMA says it is conducting its review based on the issues raised by recent notices from the US Food and Drug Administration (FDA) and World Health Organization (WHO).

According to EMA, there are several drugs that relied on studies done by Semler that are authorized in individual EU member states, though the agency notes there are no centrally authorized products that relied on studies conducted by Semler. Additionally, EMA says its review will extend to at least one ongoing marketing authorization review for a drug that used Semler studies in its application.

Data Integrity Issues

EMA's announcement comes one week after FDA notified sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) that clinical and bioanalytical studies conducted by Semler are not acceptable.

FDA made its determination after uncovering "objectionable" study practices during an inspection of Semler's Bangalore, India facility last fall. "The inspection found significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples," FDA said.

The World Health Organization (WHO) reached a similar conclusion, and issued a Notice of Concern (NOC) to Semler on 12 April, calling into question the validity of 11 studies supporting drugs prequalified by WHO and another 12 drugs currently under assessment.

Both FDA and WHO say that Semler's response to their findings fails to adequately address the issues uncovered during the inspections.

Despite the agencies' findings, Semler CEO Krathish Bopanna told Focus on Friday that his company has not committed any wrongdoing.

"We are working to respond to the timelines provided by USFDA. EMA has not inspected us, WHO is extrapolation of FDA findings. We have not indulged any activities which brings us disrepute in any manner. We will respond appropriately."

However, in its NOC, WHO says the "problems observed at Semler and other problems described in the report, indicate the existence of a general or systematic deviation from commonly accepted quality standards, and cannot be ascribed to a single person or two working outside of the quality management system."


WHO Notice of Concern

FDA Notification, Untitled Letter


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