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  • Regulatory NewsRegulatory News

    EMA Releases Draft Guideline on Epidemiological Data Requirements for Plasma-Derived Products

    The European Medicines Agency (EMA) has released a draft Guideline on epidemiological data on blood transmissible infections intended to provide clarification on the data requirements for plasma-derived products. Background In the EU, companies must submit scientific data for blood- or plasma-derived medicinal products using the plasma master file (PMF) certification procedure. The requirement for PMF certification was established in Directive 2003/63/EC , which ...
  • EMA Switches to Electronic Submission for Plasma Product Applications

    The European Medicines Agency (EMA) announced this week the launch of a new electronic form for submitting plasma master file (PMF) application to the agency, replacing two existing forms. Plasma products are protein-based medicinal products typically utilized in blood transfusions, and are regulated by EMA . Sponsors looking to obtain certification for the plasma-based product must submit the PMF, which looks to control plasma source material, data and facilities inspe...