On 8th of November 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a blog post Return to international GMP inspections announcing the resumption of international on-site GMP inspections.
In early 2020, due to COVID-19, MHRA was compelled to discontinue international on-site inspections until further notice. As travel restrictions have eased over this past year, the MHRA has launched a pilot project in April 2022, in which GMP inspectors assessed the risk of a possible return to international on-site inspections. As a result, the Authority now announced the resumption of foreign inspections. However, with still a few restrictions in some target countries, e.g. quarantine rules, the MHRA will take a risk-based approach and plans to prioritise inspections according to their criticality.
Respective manufacturing sites (MIA) should note that the Agency will contact sites with pending inspections and asks that they refrain from enquiring themselves and that the ‘expiry’ of GMP certificates issued by the MHRA will again be extended until the end of 2023.
