Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 08 December 2014 | By Alexander Gaffney, RAC
European regulatory officials have expressed concern that dozens of medicines may have been approved in the EU based on fraudulent data conducted by a contract testing facility in Hyderabad, India.
In September 2014, French regulator ANSM raised concerns about GVK Biosciences, saying a good clinical practice (GCP) inspection had "raised serious concerns regarding the GCP compliance of the conduct of the clinical part of bioequivalence trials" at the company's Hyderabad facility.
Bioequivalence trials are used to show two products are equivalent to one another, and bioequivalence data are critical for the approval of a generic drug product. As reported by Outsourcing Pharma, ANSM accused GVK employees of falsifying data, including the results of electrocardiograms.
ANSM's inspection triggered a review by EU member states to "identify all medicinal product dossiers, both approved or pending approval, that include studies conducted at [GVK's] facility." It also triggered a review by the European Medicines Agency (EMA), which said it was trying to assess "which medicines are affected by the inspection findings" to determine which ones should be suspected or withdrawn.
Then, on 5 December 2014, German regulator BfArM said it had suspended the marketing authorizations (MAs) for all products whose approval was based on bioequivalence data conducted by GVK, giving ANSM's allegations further weight.
EMA now says it plans to issue a recommendation in the coming weeks, authored by its Committee for Medicinal Products for Human use (CHMP), that will determine the scope of the problem and whether any medicines will be suspended or revoked based on the alleged fraudulent data.
EMA's review is expected in January 2015, it said.
In a statement to the India Times, GVK Biosciences said it is willing to re-do studies at another of its testing sites or to refund its customers' money.
Europe's issues with fraudulent data come after other high-profile cases in India. The US Food and Drug Administration (FDA) has issued 13 Warning Letters to Indian pharmaceutical companies this year after on-site inspections found irregular data integrity practices. Several other sites, including Ranbaxy Laboratories' manufacturing facility in Toansa, have been subject to import restrictions.
Ranbaxy also pleaded guilty to felony charges in 2013 after FDA accused it of falsifying data used to obtain approval for some of its generic drug products. A $500 million fine against the company now stands as the largest in US history against a pharmaceutical manufacturer for fraud.
Tags: Data Integrity, GVK Biosciences, ANSM, BfArM, Bioequivalence, Data