MHRA: Resumption of International GMP Inspections
On 8 November 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a blog post announcing the resumption of international on-site inspections.
Important to know: Notwithstanding, the ‘expiry’ of GMP certificates issued by the MHRA will again be extended until the end of 2023.
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 sites should note that:
- The agency will contact sites with pending inspections and asks that they refrain from enquiring themselves.
- The ‘expiry’ of GMP certificates issued by the MHRA will again be extended until the end of 2023.
Source:
MHRA: Inspectorate Blog
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