• New EMA Guideline on Depression Focused on Special Populations

    The European Medicines Agency (EMA) has announced the release of a new final guideline regarding the investigation of medicinal products intended to treat depression, providing a nuanced approach to treating depression in several subpopulations and bringing a two-year consultation process to a close. The guideline covers all products intended to treat Major Depressive Disorder (MDD) on a consistent basis, with a particular emphasis on treating major depressive episodes...
  • EMA Looks to Cut Down on Antibiotic Resistance through New Efficacy Guidelines

    The European Medicines Agency (EMA) has announced the release of a new draft guideline regarding the testing of veterinary antibiotics, with regulators saying the changes provide greater detail on their expectations for demonstrating efficacy relative to a targeted microorganism. The guideline is in part intended to cut down on rates of increasing antimicrobial resistance, EMA wrote in an accompanying statement, with the theory being that ineffective drugs only serve to ...
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    Good Clinical Practice: Where Ethics and Quality Meet

    What Is Good Clinical Practice (GCP)? When clinical research professionals are asked why they do things the way they do, they often reply, "because it's GCP!" Good Clinical Practice, or GCP, should form the foundation for all activities that take place within clinical research.  The US Food and Drug Administration (FDA) defines GCP as: "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials th...
  • New EMA Guideline Establishes Framework for Biosimilars, Use of International Comparator Studies

    The European Medicines Agency (EMA) has just published a new biosimilars draft guideline for consultation that outlines the general principles that industry must take into account when developing an application to the agency. 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 afte...
  • New Data Show Clinical Trials Conducted Outside of US, EU Have Nearly Doubled since 2005

    A new "comprehensive analysis" conducted by the European Medicines Agency (EMA) has found that more than 60% of patients enrolled in pivotal trials submitted in support of drug applications-that is, Phase III clinical trials meant to assess a drug's efficacy and safety in a large patient population-were recruited from outside of the European Economic Area (EEA), calling attention to the difficulties regulators face in policing global clinical trials. Background The repo...
  • EMA Publishes New Lupus Guideline Intended to Spur Development of New Therapies

    The European Medicines Agency (EMA) has published a new guideline on medicines for the treatment of lupus, its first on the topic. Lupus erythematous (LE) is a chronic auto-immune inflammatory disease that manifests itself in either cutaneous (CLE) or systemic (SLE) form In a statement released on 5 March 2013, EMA explained that while advancements in care have dramatically reduce mortalities and morbidities associated with the disease, "Many patients still have incompl...
  • EMA Regulators Release ICH Guideline on Genotoxic, Carcinogenic Starting Materials

    EU regulators have released for public consultation a guideline under development by the International Conference on Harmonisation (ICH) intended to establish the best practices for controlling carcinogenic risk in pharmaceutical products when those products are made using genotoxic or carcinogenic starting materials. That guideline, M7 Guidelines on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk ...
  • ICH Manufacturing Impurities Guideline Goes to FDA, EMA, MHLW for Consideration

    The International Conference on Harmonisation (ICH), the international pharmaceutical regulatory harmonization body, has released a draft guidance on the best practices for controlling carcinogenic risk in pharmaceutical products when those products are made using genotoxic or carcinogenic starting materials. That draft guideline, M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceutical to Limit Potential Carcinogenic Risk , is now awaiting ac...
  • EMA Releases Draft Guideline on Biosimilar Heparin Products

    The European Medicines Agency (EMA) has released a draft scientific guideline on the development of biosimilar low-molecular-weight heparins, a type of medical product often used in surgical settings as an anticoagulant and incorporated into a wide range of products. The guideline specifically pertains to two types of heparin: low molecular mass heparins (LMMH) and low molecular weight heparins (LMWH), both typically sourced from the intestinal mucosa of pigs. Non-Cli...
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    Seeing the Bigger Audit Picture with an Enterprise Quality Management System

    If you ever want to watch a lively debate, bring together three groups-Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) auditors-and tell them to find common ground for their processes so they can coexist in the same system. They will look at one another's processes and find things that are totally foreign, and conclude that they cannot do it. You know what? They are right. GLP auditors are responsible for assuring the qu...
  • UK's NICE Releases Draft Guidance on Diagnosis and Treatment of Hepatitis B

    The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has issued a draft guideline on the  diagnosis and management of chronic hepatitis B in children, young people and adults , explaining that only pegylated interferon and nucleoside or nucleotide analogues have been cleared for use by the National Health Service (NHS). The guideline, released for consultation on 17 January 2013, also noted that although substantial pr...
  • NICE Draft Guidance Recommends Drugs Not Indicated for Familial Breast Cancer

    The National Institute of Health and Clinical Excellence (NICE), the UK's cost containment agency, has updated a draft guideline on familial breast cancer treatments in which it recommends the use of tamoxifen or raloxifene as preventive treatments despite the fact that neither is approved for that indication by safety regulators. The draft, released 15 January 2013, recommends that a patient's physician or oncologist should follow the General Medical Council's (G...