According to the Handling and Transplantation of Cells, Tissues and Organs Act1biovigilance means the provision of information concerning any serious adverse effect associated with the handling of cells, tissues and organs and any serious adverse reaction occurring at the time or after transplantation of cells, tissues or organs into a recipient, and the procedure for establishing the reasons thereof.
A serious adverse event (SAE) is defined as any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues 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.
A serious adverse reaction (SAR) is defined as 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, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.
It is important to ensure the traceability of human cells, tissues and organs through the procedure, from donor to recipient and vice versa, in order to discover and investigate serious adverse reactions and serious adverse events and recall the cells, tissues and organs which do not meet the criteria of quality by effective means and without delay.
Notification of serious adverse events and serious adverse reactions
Under the legislation, all handlers of cells, tissues and organs (tissue establishments) are required, through the Responsible Person (or designee), to notify the State Agency of Medicines of and provide a report analysing the cause of and ensuing outcome of SAE or SAR.
The report has to be submitted to the State Agency of Medicines within seven days. If the report cannot be prepared within seven days, the handler shall submit an interim report concerning the course of investigation to the State Agency of Medicines and notify the State Agency of Medicines of the time of the submission of the final report.
Handlers have to submit annual reports concerning serious adverse events and serious adverse reactions which occur during a calendar year to the State Agency of Medicines not later than by 1 March of the following year.
Formats are presented in Annexes 3 and 6 of Regulation No. 81
Based on the information forwarded to the State Agency of Medicines, an annual consolidated report concerning the serious adverse effects and the serious adverse reactions is prepared by the State Agency of Medicines.
The State Agency of Medicines has to be notified of exceptional release of cells, tissues or organs within twenty-four hours. For that purpose the formats presented in Annexes 4 and 5 of Regulation No 81 have to be completed and the reason for release and a presentation of the risk assessment and the confirmation of a competent person concerning the consent of the recipient have to be indicated.