The Medicines and Healthcare products Regulatory Agency (MHRA) is now operating a risk-based process for Good Clinical Practice (GCP) inspections of organisations engaged in clinical trial activities in the UK.
The new system will combine information gleaned from Compliance Reports supplied to the MHRA by trial sponsors, contract research organisations (CROs) and hosting sites, as well as internal records of an organisation’s previous inspection history and organisational changes with other compliance documentation and the results of intelligence-gathering, to determine how much a specific organisation is in control of its risk.
The resulting risk assessments will be classified as high-, medium- or low-risk and inspections prioritised for organisations in the highest risk category. For internal control purposes, a small proportion of the organisations placed in the medium- and low-risk categories will be randomly selected for inspection, the MHRA added.
Inspections will be planned according to the level of resources available to the MHRA in the coming year, with the results of the Compliance Report giving a rough idea of the time needed to conduct the inspection.
Completion of GCP compliance reports by sponsors, CROs or hosting sites is not mandatory, the MHRA pointed out. However, failure to do so will result in the organisation involved being assigned to a high-risk category. At present, Phase I units and individual inspectors who are not acting as sponsors of clinical trials are not obliged to fill in a Compliance Report.
Explaining the shift to a risk-based system, the MHRA said there had been significant developments in inspection risk management in the UK over the past three years, which led the agency to review the strategies of a number of other regulators.
The underlying philosophy, the MHRA explained, is that “the scope, frequency and depth of inspections should be dependent on how the regulated organisation takes responsibility for compliance with the regulations. Whilst the company or organisation has always had legal responsibility for compliance, the notice of inspection has for some been a trigger for compliance assessment instead of a continuous compliance programme being in place”.
Initially a draft risk-based model was designed to cover all good practice (GxP, e.g., Good Manufacturing Practice, GCP, Good Laboratory Practice) inspections. At the level of implementation, though, “it is envisaged that there will be a different emphasis within the individual elements as appropriate to the different GxPs”, the agency commented.
