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  • Regulatory NewsRegulatory News

    European Commission Recommends Changes to SmPC, Package Leaflets

    The European Commission last week released a report detailing recommendations to improve the information provided to patients and healthcare professionals for approved drugs. In its report, the Commission says that the European Medicines Agency (EMA) should update its guidelines to improve the comprehension and readability of package leaflets (PL) and summary of product characteristics (SmPC) to safe use of drugs in the EU. The report itself takes into account the resul...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Looks to Cut PML Risk in Patients Taking MS Drug Tysabri (18 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Aims to cut Risk of PML in Patients Taking Biogen’s Tysabri with Frequent MRI Scans The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Tysabri, the Biogen multiple sclerosis drug associated with increased risk of developing progressive multifocal leukoencephalopathy (PML). To mitigate this danger, PRAC is recom...
  • Draft Guideline on Labeling Immunoglobulin Products Released by EMA

    The European Medicines Agency (EMA) has released a new draft guideline for sponsors of human normal immunoglobulin for subcutaneous and/or intramuscular administration pertaining to the summary of product characteristics (SmPC) required to be submitted to EMA and the European Commission. The guideline, released 31 July 2012 by EU regulators, notes sponsors of the products will be required to list different SmPCs on the product depending on whether it is intended for subc...
  • EMA Opens Consultation on Product Information Changes

    The European Medicines Agency (EMA) has opened a consultation on the information changes to the summary of product characteristics (SmPC) and package leaflets mandated by the new European pharmacovigilance law.   The legislation requires the addition of information to the SmPC, which is aimed at healthcare professionals, and to the package leaflet, which is aimed at patients and consumers. This information is to include: a statement and a black symbol for m...