EMA Maintains Recommendation to Suspend Drugs for Data Integrity Issues

Regulatory NewsRegulatory News | 22 May 2015 |  By 

The European Medicines Agency (EMA) has reconfirmed its recommendation to suspend the authorization of medicines that relied on clinical studies performed by Indian contract research organization GVK Biosciences.


In January, EMA recommended EU member states suspend the marketing authorizations for products whose approval relied on GVK studies, citing concerns over "systemic" data manipulation alleged by the French National Agency for Medicines and Health Products Safety (ANSM).

During a 2014 inspection, ANSM said it uncovered evidence of data manipulations for electrocardiograms (ECGs) that were performed as part of many of the clinical trials. The French regulator found the tampering to be widespread, which EMA says "cast doubt on the integrity of the conduct of the trials … and on the reliability of data generated."

In total, EMA's Committee for Medicinal Products for Human Use (CHMP) reviewed the authorizations for more than 1,000 forms and dosages of drugs that GVK conducted trials for. The review concluded that more than 700 of the products lacked sufficient data from other sources to maintain marketing authorization.

Suspension Upheld

Following EMA's recommendation, several companies whose products were recommended for suspension called for a reexamination of the review. After concluding the reexamination, CHMP is maintaining its previous recommendation, saying the committee still had "concerns about the reliability of the clinical studies."

EMA maintains that "there is no evidence of harm or lack of effectiveness" for any of the products recommended for suspension, and says member states should maintain access to any "critical" medicines. For products that are not suspended out of critical need, companies have 12 months to provide EMA with additional data to support the product's authorization.

The recommendation is now being sent to the European Commission, where a legally binding decision will be made for the affected products.


EMA Press Release


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy