The Medicines and Healthcare products Regulatory Agency (MHRA) falls short of best practice safety management and governance seen in other safety critical sectors such as nuclear, aviation, defence and oil/gas. Shortcomings include:

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● no process for investigating fatal/serious Yellow Card reports;

● no independent safety audits of MHRA;

●lack of accountability and no predetermined safety thresholds in stark contrast to regulators of other industries;

●close funding arrangements involving the pharmaceutical industry, creating serious conflicts of interest.

The serious shortcomings identified raise grave concerns about the ability of MHRA to fulfil its statutory duty to protect the public from harm, by properly regulating the safety and effectiveness of medicines in the UK. Given the level of reported Covid-19 vaccine injuries and the excess deaths across all age groups, these products must be paused while they are properly investigated, and a full independent inquiry launched into MHRA’s regulatory processes and performance.