EU Commission starts inspection guidelines talks

The European Commission has launched public consultations on three detailed sets of guidelines affecting the EU pharmaceutical industry: on inspection procedures for checking that good clinical practice rules are being followed; on qualifications for inspectors carrying out this work; and on the archiving of good clinical practice files by EU and national authorities.

On inspection procedures, the relevant paper says that these should be harmonised by EU and national agencies 'through joint inspections, agreed processes and guidance, and sharing of experience and training.' The document includes notes on legal affairs, administrative structures, confidentiality, follow-up inspections, personnel and training.

Regarding inspectors, the paper includes rules on training and education, management abilities, and periodic reviews of their skills. It adds that a lead inspector in EMEA coordinated inspections should speak and write English.