COVID-19: UK MHRA Says Non-Essential Inspections Will Be Office-Based
Unannounced On-Site Inspections Still On Cards To Protect Public Health
The UK’s Medicines and Healthcare products Regulatory Agency is replacing all non-essential on-site inspections with office-based assessments due to the coronavirus pandemic. The agency also plans to rely on information from international regulatory partners to maintain oversight.
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The UK Medicines and Healthcare products Regulatory Agency is testing a new remote, office-based inspection process, in place of physical inspections, to assess risk at “satellite sites” that perform a limited number of good distribution practice-related activities for companies.
The UK medicines regulator is exploring how it can focus its pharmacovigilance inspections on areas of high-risk and reduce the number of days it spends on inspections. To this end, office-based inspections have emerged as a useful concept, and there are plans to use this approach more vigorously.
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