The Learning Portal will be under maintenance Friday, 28 January from 10PM to 12AM. Portal functionality may be unavailable intermittently during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    EMA Maintains Recommendation to Suspend Drugs for Data Integrity Issues

    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. Background 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 Pr...
  • Regulatory NewsRegulatory News

    FDA Says Chinese API Manufacturer Falsified Drug Data

    The US Food and Drug Administration (FDA) has sent a Warning Letter to a Chinese active pharmaceutical ingredient (API) manufacturer after finding that the firm did not exercise proper control over its manufacturing data. Background The Warning Letter, sent to Yunnan Province-based Yunnan Hande Bio-Tech, is the latest in a long string of warnings from FDA related to data integrity concerns. As detailed by Regulatory Focus , more than a dozen Indian drug manufa...
  • Regulatory NewsRegulatory News

    FDA Issues Stern Warning Letter to Hospira Over Manufacturing Lapses in Italy

    The US Food and Drug Administration (FDA) has just issued biopharmaceutical manufacturer Hospira a new Warning Letter—the company's seventh in the last seven years —regarding alleged deficiencies found at the company's Liscate, Italy manufacturing facility. Background The letter, issued 31 March 2015, references a May 2014 inspection of Hospira's Liscate facility where the company manufactures finished pharmaceutical products. During the seven-day inspection, FDA said...
  • Regulatory NewsRegulatory News

    Drug Manufacturer Lacked Adequate Controls Over Manufacturing, FDA Warns

    A Thailand-based active pharmaceutical ingredient (API) manufacturer has been warned by the US Food and Drug Administration (FDA) for failing to ensure that its manufacturing data could not be altered or falsified—claims similar to those levied against many Indian pharmaceutical companies. In a 27 February 2015 Warning Letter to Novacyl Ltd, FDA references an April 2014 inspection of the company's Samukprakam, Thailand manufacturing facility. There, FDA said it "identifi...
  • Regulatory NewsRegulatory News

    FDA Chides Two More Indian Drug Manufacturers for Potential Testing Fraud

    The US Food and Drug Administration (FDA) has issued two warning letters to Indian pharmaceutical manufacturers Apotex and Micro Labs, accusing both of potentially falsifying the data used to show their drugs were made to federal quality standards. Background The letters are similar in nature to nearly a dozen others sent to Indian pharmaceutical manufacturers since May 2013. To date, FDA has sent 15 letters to Indian companies accusing them of violating standards on en...
  • Regulatory NewsRegulatory News
    TrackersTrackers

    India's Data Integrity Problems

    In recent months, the US Food and Drug Administration (FDA) has identified more than a dozen Indian pharmaceutical manufacturers who have had problems with the data integrity practices at their respective facilities. Those data are intended to ensure that products meet pre-established specifications, such as for purity, potency, stability and sterility. In the absence of credible data, the concern is that these products cannot be trusted. And indeed, FDA has subject many...
  • Regulatory NewsRegulatory News

    EMA Recommends Suspending Drugs over GVK Data Integrity Issues

    The European Medicines Agency (EMA) is  recommending EU Member States suspend products whose approval relied on clinical trials conducted at GVK Biosciences in Hyderabad, India. The agency cites concerns over “systemic” data manipulation alleged by the French National Agency for Medicines and Health Products Safety (ANSM) following an inspection of GVK’s site in May 2014. For more about the allegations against GVK see our December 2014 article, “ EU Regulators Conce...
  • Regulatory NewsRegulatory News

    EU Regulators Concerned About Drug Data Fraud by Indian Company

    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. Background 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...
  • Regulatory NewsRegulatory News

    FDA Warns Indian Generics Manufacturer Cadila Over Data Integrity Issues

    The US Food and Drug Administration (FDA) has issued a stern warning to the Indian pharmaceutical manufacturer Cadila regarding various deficiencies at its drug production facility in Ahmedabad, including serious problems with the systems needed to ensure testing data isn't falsified. Background The letter to Cadila is the 13th sent by FDA to an Indian pharmaceutical company regarding so-called "data integrity" issues since May 2013. For a complete listing, ple...
  • Regulatory NewsRegulatory News

    FDA Finds Falsified Data, Serious Mold and Decaying Frogs at Pharmaceutical Company

    For at least the 12th time since May 2013, the US Food and Drug Administration (FDA) has sent a Warning Letter to an Indian pharmaceutical manufacturer accusing it of falsifying data used to support the ongoing approval of its drug products. For more on Indian Companies' data integrity problems , please see our updated tracker tool here . Falsified Data The company, Marck Biosciencies, was subject to an October-November 2013 inspection by FDA at its Kheda, ...
  • FDA to Spend up to $10 Million Strengthening Regulation in South America

    • 17 July 2014
    US regulators are planning to work more closely with a global health group focused heavily on South America in the hopes of strengthening medical product regulatory systems across the region. In an announcement on 8 July 2013, the US Food and Drug Administration (FDA) said it plans to award the Pan American Health Organization (PAHO) a contract to help "foster regulatory collaboration and strengthen regulatory capacity throughout the Americas." Regulatory capacity broad...
  • Regulatory NewsRegulatory News

    Italian API Manufacturer Warned by FDA Over Missing Data

    An Italian active pharmaceutical ingredient (API) manufacturer has received a Warning Letter from the US Food and Drug Administration (FDA) chiding the company for allegedly deleting all of the data meant to ensure that its product was manufactured to specifications. The 15 July 2014 letter follows a January 2014 inspection of Trifarma S.p.A.'s manufacturing facility in Rozzano, Italy. There, FDA said its inspectors found several violations of its regulations on good ma...