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  • 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...
  • 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Conference on Harmonisation (ICH), the international pharmaceutical regulatory harmonization body, has released a draft guidance on the best practices for controlling carcinogenic risk in pharmaceutical products when those products are made using genotoxic or carcinogenic starting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...
  • 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...
  • India Issues Draft Drug GDP Guidance

    India's Central Drug Standards Control Organization (CDSCO) released on 10 January 2013  draft guidelines  on good distribution practices (GDP) for pharmaceutical products intended to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. Elements of the process include, but are not limited to, procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices.  The...
  • Indian Regulators Finalize Recall System Requirements

    Just weeks after releasing draft guidelines on a new recall system, India's Central Drugs Standard Control Organization (CDSCO) has finalized its recall and rapid alert system for chemical and biological drugs, bringing the country much more closely in line with the recall standards of most established regulatory authorities. The draft guideline , released in late October, was available for public comment for 15 days. A side-by-side analysis of the draft and final guide...
  • EMA Releases Draft Guideline on Hepatitis B Vaccines

    The European Medicines Agency (EMA) has released a new guideline to instruct sponsors of clinical trials on best practices for assessing antibody-based products used to prevent the hepatitis B virus. The 2 December 2012 draft guideline, On the Clinical Investigation of Hepatitis B Immunoglobulins , is specifically aimed at vaccines, which EMA explains are an effective method for protecting uninfected, healthy individuals against infection by the hepatitis B virus. T...
  • Revisions to Osteoporosis Guideline Called for by EMA

    The European Medicines Agency (EMA) has released a new concept paper calling for revisions to the way osteoporosis products are evaluated in the EU, saying existing guidelines are largely inadequate to assess a secondary form of the disease. The problem, explained EMA, is that current osteoporosis guidelines only cover primary osteoporosis, and do not address the evaluation of products used to treat secondary osteoporosis, often brought on by glucocorticoid therapy. Gl...
  • India's CDSCO Releases Proposed Changes to Recall System with Focus on Timelines

    India's Central Drugs Standard Control Organisation (CDSCO) has released a new draft guideline on a new recall and rapid alert system for chemical and biological drug products , bringing it more closely into line with the recall system used by US regulators. The intent of the rapid alert system is to place special emphasis on urgent recalls with the potential to seriously affect patients or the consuming entity (in the case of veterinary products, animals). These alerts...