MHRA May Reduce the Number of Inspections for Compliant Firms

Firms that comply with good practices may be rewarded with fewer inspections if the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) implements a new proposal.

In an effort to reduce regulatory burdens, the MHRA wants to revamp its risk-based inspection program for good practice inspections to allow more flexibility in the frequency and intensity of inspection activities.

The agency’s consultation applies to all manufacturers, importers and wholesale distributors of human medicines and investigational drug products, contract research organizations, pharmacovigilance activities and medical laboratories.

The proposal would transform the existing risk-based inspection program into one based on random inspection, inspection element, corporate compliance element, self-assessment element, intelligence element, risk-profile element, inspector risk-assessment element and risk management review board.

“Medicines and Healthcare products Regulatory Agency (MHRA) — Consultation on a Risk-Based Inspection Programme for Good Practice Inspections” can be accessed at www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2032819&ssTargetNodeId=373. Comments are due Jan. 15, 2008.