Guidance for industry on MHRA’s expectations for return to UK on-site inspections

11th August 2020

The MHRA suspended their on-site GxP inspection programme on 20 March 2020 in response to COVID-19 social distancing and travel restriction requirements.

In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based GxP inspection programme starting in September, scaling up to a full programme from October 2020. This will use a combination of remote and on-site inspection approaches as COVID-19 restrictions are eased. The MHRA is committed to working with industry to reduce regulatory burden during the COVID-19 pandemic wherever possible, including flexible approaches to inspection, but this does not diminish or impede the agency’s regulatory powers to inspect.

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