U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is creating a comprehensive “Risk Intelligence IT System” for determining where to deploy its inspection resources that captures and analyzes a wide variety of inputs from industry, public, and agency information sources.
Data feeding into the revamped risk-based inspection planning system will include: ● agency inspection reports ● network market intelligence ● media reports – for example, dramatic shifts in company share prices ● information from whistle-blowers, and ● information from other government regulatory agencies such as FDA or Australia’s TGA.
The new system complements a broader MHRA effort that is aimed at improving its interactions and communication with industry and getting a better handle on where compliance and drug shortage risks are located before they manifest themselves.
At a PharmaLink conference in March in Cincinnati, Ohio, co-sponsored by FDA and Xavier University, MHRA GMDP Inspections Group Manager Mark Birse reviewed his agency’s initiatives in these areas.
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