eCTD submission

European Medicines Agency’s updates

Following is the list of recent EMA”s updates with links to updated documents/guidelines:

  • Heads of Medicines Agencies
  • Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes
  • Regulatory and procedural guideline: Procedure for reporting of pharmacovigilance inspections requested by the CVMP, adopted
  • Quality control of medicinal-product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004 (updated)
  • eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) bulk update manager
    Questions and answers relating to open tender ”Effectiveness and pharmacoepidemiology studies” – reference number EMA/2014/50/RE
  • List of medicinal products under additional monitoring
    The European Union regulatory network incident management plan for medicines for human use
    Referral: Article 20 procedures, Maci, matrix-applied characterised autologous cultured chondrocytes

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