China to implement new regulation for on-site inspections at the clinical sites and manufacturing facilities

National Medical Products Administration (NMPA) released “Regulations for on-site inspections at the clinical sites and manufacturing facilities” for public comment

For sponsors that have submitted drug applications to the NMPA, on-site inspections will look into the pre-clinical and clinical studies and manufacturing processes conducted in China. The purpose is to confirm all the records are Attributable, Legible, Contemporaneous, Original, Accurate and Complete (ALCOAC criteria) as well as reliable, secure and accessible. There will be Extended Inspections that focus on manufacturing sites of APIs, excipients and packaging materials and the vendors as well as third party service providers.

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