MHRA GCP Inspection Metrics

The MHRA published in March 2023 their ‘GCP Inspections Metrics Report’, covering the period from 1 April 2019 to 31 March 2020.

I am pretty sure no regulatory agency would accept my 2019-2020 Annual Product Quality Review (APR/PQR) being published 3 years late. Regulatory agencies need to hold themselves accountable and are fairly poor at doing so. The EMA is not alone at this, the recent EMA report was two year old data.

The MHRA GCP inspectors reported the following observations in the two-year period:

  • Commercial sponsors: 4 critical, 17 major, 34 other. All critical observations were related to pharmacovigilance (PV).
  • CROs: 4 critical, 25 major, 41 other. Critical observations were related to data integrity, IMP management, and protocol compliance.
  • Non-commercial sponsors: 4 critical, 12 major, 26 other. Critical observations were related to clinical sample analysis, data integrity, sponsor oversight, and PV.
  • Phase I Units: 1 critical, 8, major, 28 other. The critical observation was related to dose escalation.
  • Investigator Sites: 0 critical, 17 major, 64 other.

As always, a very good document to perform a gap assessment against.

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