Mutual Reliance Blossoming Among FDA, EMA, Other Inspectorates
This article was originally published in The Gold Sheet
FDA, EMA and other agencies are increasingly relying on each others' inspection results in an effort to spread their inspectional resources throughout the furthest corners of the globe. Inspection coordination remains somewhat ad hoc, with EMA keeping a spreadsheet for some and PIC/S enabling others. EMA's EudraGMP database is touted as a coordination hub.
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Regulators report that an international collaboration on GMP inspections of API sites has bolstered the exchange of information between participating health authorities, yet the information technology system that supports the system could use some improvement.
MHRA has begun sifting data with powerful software to help the British inspectorate set GMP inspection priorities – and even to alert companies to emerging issues so they can take steps to stay out of trouble. Other agencies show interest in using the system, which would enable data sharing that could make it even more sensitive and confident in its risk analysis.
PIC/S, the world’s ‘club’ of pharmaceutical inspectorates, is considering making life easier for manufacturers by helping members align their views on deficiencies and reduce inspection redundancies. But much depends on the club’s ability to bring more inspectorates into the fold, particularly those of the emerging BRIC nations.