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16.11.2022

MHRA resumes international Inspections

Recommendation

2/3 September 2026
Copenhagen, Denmark

Root Cause Analysis
When “Human Error” isn’t enough: Successful Failure Investigation

Right at the start of the Covid 19 pandemic, in March 2020, the UK MHRA published a blog post on the progress of on-site inspections. These were limited to inspections related to the UK government's COVID-19 response or other potential serious public health risks. As the pandemic and developments unfolded, more on-site inspections were then carried out again in the UK. However, there was not really a return to international inspections.

Meanwhile, international travel has become easier to organise again. A pilot programme has started in April 2022 to look at a possible return to international GMP on-site inspections. In a MHRA Inspecctorate Blog entitled "Return to International GMP Inspections" now published, it is announced that the pilot project was successful and the MHRA is resuming the programme of international GMP on-site inspections, albeit with restrictions. A risk-based approach will be taken.

Validity of GMP certificates

During the pandemic, a "pragmatic approach" was taken to the validity of GMP certificates. These were first extended to the end of 2021 and then to the end of 2022. The blog now also states that GMP certificates issued by the MHRA will be extended again until the end of 2023.