General Office of the State Council, Plan for a Pilot Project for the Marketing Authorization Holder System for Pharmaceuticals

Main contents: A pharmaceutical research and development institution or researcher in a pilot administrative region may, as a pharmaceutical registration applicant (an Applicant), submit a pharmaceutical clinical trial application or pharmaceutical marketing application. If the Applicant secures marketing authorization and a pharmaceutical approval document number, it/he/she may become a marketing authorization holder (an MAH). The legal liability relating to pharmaceutical clinical trials and pharmaceutical production and marketing specified in laws and regulations shall be borne by the Applicant or MAH as appropriate.