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  • Regulatory NewsRegulatory News

    EMA Assesses Concerns With Indian Generic Firm’s Clinical Data

    The European Medicines Agency (EMA) has begun a review of medicines for which studies have been conducted at Alkem Laboratories’s site in Taloja, India due to data integrity concerns. The review follows a joint good clinical practice (GCP) inspection of this site by German and Dutch regulators in March 2015, which raised issues with study data used to support the marketing authorization applications of some medicines in the EU. Following consideration of the inspectio...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Looks to Protect Clinical Data Integrity (5 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Introduces Draft Clinical Trial Data Verification Procedures The China Food and Drug Administration (CFDA) has released a provisional document regarding the validation of clinical trial data. Under the model, CFDA’s audit team will conduct on-site assessments of the records kept by clinical trials to verify the authenticity and integrity of data purporting to show the ...
  • Regulatory NewsRegulatory News

    FDA Warns Indian Drugmaker Over Major Data Integrity Violations at Three Plants

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to India-based Ipca Laboratories after inspections at three of its manufacturing facilities revealed data integrity violations. All three of the plants are already banned from sending products to the US. The warning letter, dated 29 January, reveals how inspectors found “systemic data manipulation” at Ipca’s Ratlam facility in Madhya Pradesh, “including actions taken by multiple analysts, on...
  • Regulatory NewsRegulatory News

    Health Canada Makes New Transparency Pledge

    Over the next three years, Health Canada says it will enhance its early warning systems on drug and device safety issues, particularly those in other countries, further communicate explanations for regulatory decisions and update and expand guidance on regulatory requirements. The plan, laid out by the agency this week, also points to the need for more inspections of pharmaceuticals, medical devices and other health product businesses that it regulates. Building off of...
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    FDA Warns Sun’s India Plant Over Sterility Concerns

    Serious aseptic and sterility violations, including water damage and leaks in parenteral manufacturing areas, were documented by the US Food and Drug Administration (FDA) in the latest warning letter for Sun Pharmaceutical’s manufacturing plant in Halol, India. Since the September 2014 inspection, FDA has withheld future product approvals from the Halol facility. The company was cited in a separate warning letter in May 2014 for data integrity concerns (trash bags...
  • Regulatory NewsRegulatory News

    Health Canada Overruled on Apotex Import Ban

    A Canadian federal court has ruled against Health Canada’s decision to restrict pharmaceutical imports from two Apotex facilities in India, though the US FDA still bans products from these facilities. In its ruling from 14 October, the court noted that Health Canada and Health Minister Rona Ambrose proceeded unfairly and acted for an improper purpose. The ruling also requested Health Canada and Ambrose retract its statements on Apotex, which they did Tuesday. And altho...
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    FDA Warns Indian API Manufacturer for Data Integrity Issues, Wild Lizard

    The US Food and Drug Administration (FDA) on Tuesday again revealed data integrity deviations in India, this time from an inspection of Unimark Remedies' facility in Bavla, India, which produces active pharmaceutical ingredients (APIs) for at least two antibiotics – cephalosporin and carbapenem. Since 2013, more than a dozen Indian API and pharmaceutical manufacturers have been cited by FDA for data integrity problems. Data Integrity When FDA inspected Unimark from ...
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    WHO Raises Serious Concerns With Indian TB Drugmaker

    World Health Organization (WHO) inspectors earlier this week released a letter uncovering a number of safety issues at a Mumbai-based manufacturer of tuberculosis drugs. WHO said its inspection at the facility of Svizera Labs, which is part of Maneesh Pharmaceuticals, from June 2015 uncovered several critical and major deviations from WHO Good Manufacturing Practice standards and this latest Notice of Concern letter includes deficiencies that are still a problem for the ...
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    WHO: 'Critical' Data Integrity Issues Found at Indian CRO

    Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last October. Background As part of its Prequalification of Medicines Programme , WHO carries out inspections of companies involved with clinical research and manufacturing to ensure prequalified medicines are of "acceptable quality, safety and efficacy." The program focuses on prod...
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    Keeping an Eye on Corporate Integrity Agreements

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.   The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Even in the world of healthcare product regulation, the initials CIA sti...
  • Feature ArticlesFeature Articles

    Evolution of Board Responsibility for Compliance Program Oversight

    Will the Pfizer Class Action be the Missing Link? This article examines how OIG's expectations of the role played by a company's Board of Directors in overseeing corporate compliance programs have changed over time in a manner corresponding to Audit Committee requirements of Sarbanes-Oxley. In March 2015, a US district court tentatively approved the settlement of a class action lawsuit filed against Pfizer Inc., in connection with the off-label promotion of a number...
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    API Manufacturer Warned by FDA Over Contamination, Data Integrity Issues

    A Czech manufacturer of active pharmaceutical ingredients (APIs) has been warned by the US Food and Drug Administration (FDA) for allegedly releasing products contaminated with bacteria. The company, VUAB Pharma of Roztoky, Czech Republic, was issued a Warning Letter by FDA on 27 May 2015 following a June 2014 inspection of the facility by FDA investigators that found "significant deviations from current good manufacturing practice (CGMP)." In one notable allegation, F...