What are the obligations of the HTA in relation to serious adverse events and reactions?
The HTA, as a competent authority under the 2007 Regulations implementing the European Tissues and Cell Directive 2004/23/EC, has a statutory obligation to ensure that systems are in place to report, investigate, register and transmit information about SAEs and SARs. This includes a duty to communicate information about any SAEs or SARs to other relevant persons or bodies such as: persons and establishments carrying out human application activities, other competent authorities and to the European Commission. This allows appropriate action to be taken if tissues or cells need to be withdrawn or control measures are required. In compliance with this requirement the HTA issues regulatory alerts if it becomes aware of circumstance affecting a number of tissue establishments. The authority is also required to keep a register of SAEs and SARs and to make this information available to the public in a manner that it considers appropriate. The HTA has included information about SAEs and SARs in
