NMPA to Strengthen Management of Entrusted Production in Marketing Authorization Holders

On May 24, 2023, National Medical Products Administration (“NMPA”) released the Circular on Strengthening Management of Entrusted Production in Marketing Authorization Holders (Exposure Draft) (the “Circular Draft”) for public comment until June 23, 2023.

The Circular Draft calls for strengthening licensing and quality management of entrusted production, as well as supervision and inspection of marketing authorization holders that entrust production. It requires provincial drug regulatory departments to inspect an applicant on the site, with the focus placed on the particulars of the applicant’s staffing in key positions, the construction of quality management system and their management of entrusted production. It is clarified that a marketing authorization holder should set up a management division with clear responsibilities, equip itself with the management personnel that are in line with its drug production and operation scale, step up its management of the incoming inspection of raw materials, auxiliary materials, packaging materials and containers that are in direct contact with drugs, and enhance its management of the ex-factory inspection of preparation products.