As part of its risk-based inspections regime which ensures compliance with statutory obligations relating to medicines the Medicines and Healthcare products Regulatory Agency (MHRA) is implementing new IT software. MHRA inspections across all the disciplines will be better prioritised as a result, helping to target its activity to the areas of greatest risk and ultimately help protect public health. This risk-based approach helps reduce the overall administrative and economic burden on companies and organisations operating in the public health arena who are regulated by MHRA and who demonstrate a high level of compliance.

Gerald Heddell, the MHRA’s Director of Inspections, Enforcement and Standards, said: “It’s vital we move with the times and this new software will help collate all the information we need in one location to make informed risk-based decisions on those we inspect and improve our capability to ensure the quality of medicines used in the UK. Our inspectorate teams will focus their time on inspections in order of priority from the risk signals flagged. We have a defined resource and an increasing number of inspections we require to consider. This information available will ensure that our resource is utilised effectively and that less inspection time is spent on companies with a good compliance record, and therefore a lower risk.”

Mark Hammond, Accenture managing director of Life Sciences’ Research & Development practice for UK/Ireland, said: “The enhanced use of data to inform decision-making is critical to enabling the MHRA to fulfil its responsibility to industry and the general public. We are pleased to build on our long-standing relationship with the MHRA and play a role in the development of this leading-edge proposition, supporting the Agency’s continued innovation around regulation and compliance.”

“MHRA, through its inspection processes and programs, plays an essential role in safeguarding public health. The ability to apply resources to the areas of greatest potential risk is vital to optimizing the agency’s resources and impact,” said Neil de Crescenzo, senior vice president and general manager, Oracle Health Sciences.  “We are delighted to work with MHRA on this innovative initiative.”


Posted on the UK MHRA websgtie on 12 March 2013