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Ireland's HPRA: Guidance on Requirements for Reporting Serious Adverse Reactions and Events with Human Tissues and Cells

Last Friday (09 February 2024) the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Guide to Serious Adverse Reaction/Event Reporting for Human Organs Intended for Transplantation" which aims to ensure timely and effective reporting of such events to facilitate risk assessment and management in the field of organ transplantation.


Serious adverse reaction (SAR): An unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, lifethreatening, disabling, incapacitating or which results in, or prolongs hospitalisation or morbidity.


Serious adverse event (SAE): Any untoward occurrence associated with the procurement, testing, processing, storage or distribution of tissue and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity.


Imputability is an assessment of the likelihood that a reaction is related to a safety or quality defect in the tissue or cell or the tissue or cell donation process.


Key Highlights from the Guide

  1. Reporting Obligations: The guide clarifies the legal obligations of healthcare professionals, tissue establishments, and transplant centers to report SARs and SAEs to HPRA. It emphasizes the importance of timely and accurate reporting to facilitate regulatory oversight and patient safety.

  2. Reporting Criteria: Detailed criteria are provided for determining whether an adverse reaction/event should be classified as serious and therefore subject to reporting. This includes considerations such as severity, causality, and expectedness of the reaction/event.

  3. Reporting Process: The guide outlines the steps involved in reporting SARs and SAEs, including the use of specific forms, timelines for reporting, and communication channels with HPRA.

  4. Follow-up and Investigation: HPRA may request additional information or conduct further investigations following the receipt of a SAR or SAE report. The guide helps how to respond to such requests and cooperate with HPRA's inquiries.

Benefits of Compliance

Compliance with HPRA's guidance on reporting SARs and SAEs for human organs intended for transplantation is essential for ensuring patient safety and maintaining public trust in the transplantation process. It enables HPRA to monitor the safety and effectiveness of these procedures and take appropriate regulatory actions if necessary.


To know how to fill out and submit the forms, and how HPRA will process the reports click this LINK.


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