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    EMA Recommends Suspending Alkem Drug Over Flawed Studies

    The European Medicines Agency (EMA) on Friday recommended suspending the marketing authorization of a drug made by Indian generic manufacturer Alkem Laboratories over data integrity issues at the company's bioequivalence facility in Taloja, India. In light of the issues, EMA says that studies conducted by Alkem at the facility between March 2013 and March 2015 cannot be relied on to support marketing authorizations. The recommendations stem from a review EMA launched i...
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    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...
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    EMA Takes a Firmer Stance on GCP Non-Compliance

    Drug and biotech companies cannot replace pivotal clinical trials that are non-compliant with good clinical practice (GCP) standards during the assessment of marketing authorization applications, according to a new position paper from the European Medicines Agency (EMA). Stressing the importance of GCP compliance, the EMA says it’s an “essential prerequisite” for assessing a medicinal product’s safety and efficacy. The agency also clarifies that when a study is found to...
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    Amended ICH GCP Guideline Addresses Evolution of Trials Landscape

    The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline with the aim of helping industry address the increasing scale, complexity and cost of clinical trials. The evolving use of technology and new risk management processes offer opportunities to increase efficiency, ICH says. The updated guideline is intended to provide a unified standard for the regulatory authorities in the EU, Japan, US, Canada and Switzerland to fa...
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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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    FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data

    New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards. Background The draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States , is closely related to a rule proposed by FDA in February 2013. That rule, Hum...
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    EMA Updates its Biosimilar Insulin Guideline

    The European Medicines Agency (EMA) has updated its guideline on the requirements for clinical and non-clinical development of biosimilar insulin products. The update expands the scope of the original document and gives additional detail on study design parameters. Biosimilar Medicinal Products in the EU EMA recently finalized its guideline on “similar biological medicinal products”—commonly referred to as biosimilars—which will enter into effect in April 2015. B...
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    EMA Finalizes Major Guideline on Biosimilars

    The European Medicines Agency (EMA) has finalized a long-awaited guideline containing new recommendations on how to bring "similar biological medicinal products"—also known as biosimilars—to market in the EU. Background EMA first released a draft update of the guideline, Similar Biological Medicinal Products , in early May 2013. The guideline was meant to update an October 2005 guideline on biosimilarity which officials said had become outdated. The new guidelin...
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    EMA, FDA Team Up to Propose Guideline on Pediatric Gaucher Disease

    US and EU regulators have come together to release an unusual joint proposal that they say will help speed up the development of new treatments affecting pediatric patients with Gaucher disease. Background Gaucher disease is a rare, inherited lysosomal storage disorder which affects patients by causing the buildup of lipids in cells and organs, such as the liver, spleen, kidneys and brain. It is thought that about 20,000 patients have Type I Gaucher disease in the US, a...
  • EMA Issues New Guideline on Controlling Disease Transmission Risks in Urine-Based Products

    The European Medicines Agency (EMA) is out with a new draft guideline intended for sponsors of human urine-based products, saying a standardized approach is needed to ensure that products are free from dangerous contaminants. As regulators explain in the guideline- on the adventitious agent safety of urine-derived medicinal products -human urine is used in several products, including human chorionic gonadoptropin (hCG), human menopausal gonadotropin or menotropin (HMG)...
  • EMA Updates Biosimilar Guideline to Account for Nuanced Development Approach

    The European Medicines Agency (EMA) has announced the release of a new biosimilars guideline that again looks to clarify the process by which biosimilars come to market, this time refining an earlier guideline in several areas. Background Generic products have long been an integral part of the pharmaceutical ecosystem. Starting in the 1980s, frameworks were set up around the world to allow for generic pharmaceutical companies to make chemical copies of existing drugs a...
  • EMA Releases New Guideline Meant to Clarify Process for Naming Drug Products

    Around the globe, healthcare product regulators have expressed an interest in-and occasionally concern with-naming conventions for brand-name pharmaceutical products. EU regulators are no exception to this rule, and announced this week that they have issued new revisions to a guideline regarding the acceptability of names for human medicines. Background While many consumers might consider branded pharmaceutical names a marketing tool-which they undoubtedly are-regulator...