The Medicines and Healthcare products Regulatory Agency (MHRA) is taking a number of steps to improve its performance with respect to the assessment of product licence applications and variations and its ability to meet the target processing times. These include:
the recruitment of additional information processing and assessment staff, including pharmacists and physicians, to deal with the growing complexity of licence applications and approval procedures;
extended working hours and bonus payments to staff for their information processing and assessment outputs;
additional professional assessor training to enable each assessor to deal more efficiently with a wider range of scientific issues in each application; and
improvements to the recently introduced data, document and workflow management system to improve its processing times.
The MHRA’s progress in dealing with the backlog of licence variation applications is already published on its website at www.mhra.gov.uk Once this special project is complete the MHRA will ensure that the future process provides for sustainable throughput against target times for all types of licence applications.