UK MHRA restructures in attempt to improve service
The MHRA has announced a new structure designed to improve its service. It has introduced three new divisions: Licensing; Vigilance Risk Management of Medicines (VRMM); and Information Processing and has introduced some changes to the way marketing authorisation (MA) variation applications are documented.
The MHRA has announced a new structure designed to improve its service. It has introduced three new divisions: Licensing; Vigilance Risk Management of Medicines (VRMM); and Information Processing and has introduced some changes to the way marketing authorisation (MA) variation applications are documented.
The recent implementation of a new information management programme - Sentinel - at the MHRA has caused a huge backlog of applications waiting to be processed. The situation has been exacerbated by an increase in its obligations and by a lack of trained staff. This has particularly affected high throughput areas such as variations to MAs.
The MHRA said: "We have been working continuously to improve the service levels to support our business needs and have put in place a programme of measures to achieve this." The measures include organisational restructuring, additional recruitment, retraining of staff, voluntary schemes for extended working hours, and information system performance enhancements.
The Agency will also introduce a new service desk, dedicated to handling industry queries over the coming months.
A guide to the changes is available on its website.