A new 51 page document has been released by the UK government that heaps praise on the UK Medicine Regulator [MHRA] but warns it needs to quicken its pace to keep up with the rapidly changing demands of healthcare.
"The MHRA has done much to improve communication with healthcare professionals and the public. Nor has not shied away from its problems and mistakes, or the need to take a tough stance," says the review.
The review also recommends that the Department of Health help all its public health agencies, including the MHRA, to develop a strategic network, and that the regulatory bodies should work more closely together to ensure that they deliver their public health mission.
Section 1.7 of the review reads:
"The roll out of Sentinel, a new IT system used to underpin medicines regulation work, exposed significant failings in project and financial management. Work on processing of medicines licences was severely compromised, backlogs developed and cash flow dried up. During the same period, the MHRA’s funding for devices work was reduced. A report from the Health Select Committee was critical of the Agency’s perceived relationship with the pharmaceutical industry. There were high-profile drug safety controversies (for example, over Seroxat, an anti-depressant, and Vioxx, an anti-inflammatory drug) with criticisms from some quarters of both the MHRA and of the strength of the regulatory framework. Not all parts of the Agency’s work were adversely affected by these events: it was during this period, for example, that the new blood safety responsibilities were successfully devised and implemented. However, these internal and external challenges consumed leadership, impacted negatively on some stakeholder relationships and hampered the MHRA’s ability to develop strategically."
The full 51 page review can be downloaded here
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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