MHRA to Resume On-Site Inspections in September 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has announced it will resume on-site risk-based good practice (GxP) inspections in September 2020.

According to an August 11, 2020 press release, the agency specified that the inspection program will resume in September 2020 in line with a reduction in COVID-19 restrictions, and a scale-up to a full program of inspections is expected in October 2020. On-site inspections were suspended on March 20, 2020 as a result of COVID-19 social distancing and travel restriction requirements.

A combination of remote and on-site inspection approaches will be employed as COVID-19 restrictions are continuing to be eased, the agency stated in the press release. Guidance on what companies should expect in the event of an on-site inspection are available on the MHRA’s website. Any site/organization to be inspected will receive a minimum of 14 days prior notification so that planning to minimize COVID-19 risk can be performed.

Source: MHRA