Welcome to the NOTIFY Library site where experts from across the globe collaborate to share didactic information on documented adverse outcomes associated with the clinical use of human organs, blood, tissues and cells. The data presented on the Notify Library site should be seen in the context of impressive success stories in transplantation, transfusion and assisted reproduction across the world.

  • FDA/CBER Published Six New Donor Screening Guidance Documents

    On 06 January 2025, FDA/CBER posted new guidance documents that provide updated recommendations for screening donors of human cells, tissues, or cellular or tissue-based products (HCT/Ps) for risks associated with transmission of HIV, HBV, HCV, and the disease agents associated with sepsis. In addition, a separate guidance document identifies Mycobacterium tuberculosis as a new relevant communicable disease agent or disease (RCDAD) for donors of HCT/Ps, and a general donor eligibility guidance document was updated that was previously published in 2007. All six guidance documents can be accessed at this link.

  • WHO-Notify Project biovigilance meeting

    The 2024 meeting of the NOTIFY project will take place in Washington DC on September 9 and 10. The meeting is co-organized with the US Department of Health and Human Services, Office of Infectious Disease and HIV/AIDS Policy and the U.S. Food and Drug Administration, Centre for Biologics Evaluation and Research.

    This year’s meeting will be an opportunity to discuss the progress of the NOTIFY Library and its future developments and touch key topics such as traceability and the role of experts bodies and international associations in MPHO vigilance.

     

  • New European Union SoHO Regulation

    The final approved text of the Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/ECText with EEA relevance has been published in the Official Journal of the EU and is available in all EU languages at this link.

    This new regulation establishes measures setting high standards of quality and safety for all SoHO intended for human application and for activities related to those substances in order to ensure a high level of human health protection, in particular for SoHO donors, recipients and offspring from MAR.

     

  • Circular of information for the use of Cellular Therapy Products

    The AABB Circular of Information for Cellular Therapy Products Task Force has released the Circular of Information (Circular) for the Use of Cellular Therapy (CT) Products.

    The document is intended to be an extension of the cellular therapy product label, including minimally manipulated CT products only such as peripheral blood progenitor cells, bone marrow, cord blood and leukocytes.

    For further info access the following link

The NOTIFY search engine is accessible without username and password.

The database is continually updated and currently new cases are being collected and submitted to editorial working groups in order to increase the database content and scope.