Drug; Medicaments (ICS 11.120.10)
Key points for the Inspection of Drug Marketing Authorization Holders (draft for comments) (7 page(s), in Chinese)
These Key points for the Inspection is to provide guidance for the drug supervision and administration department in the supervision and inspection of the MAH. It mainly includes institutions and personnel, quality assurance system, pharmacovigilance management, risk management, post-marketing study, documents and record management, liability compensation, vaccine MAH. etc.