Announcement of the Center for Food and Drug Inspection of NMPA on Issuing 5 Documents including the Work Procedures for Drug Registration Inspection (Trial) (No. 30 of 2021)
According to the Provisions for Drug Registration, to clarify the principles, procedures, time limits and requirements of drug registration inspection, to regulate the collaborative between manufacturing site inspection of drug registration and pre-market Good Manufacturing Practice (GMP) inspection, CFDI has organized to formulate《Work Procedures for Drug Registration Inspection (Trial)》(attachment1), 《Key Points and Determination Principles of Drug Registration Inspection (Pharmacological and Toxicological Study)(Trial)》,《Key Points and Determination Principles for Drug Registration Inspection(Drug Clinical Trials)( Trial)》 and《 Key Points and Determination Principles of Drug Registration Inspection (Pharmaceutical Development and Manufacturing Site) (Trial) 》(attachment2-4)，《Work Procedure for Collaborative Drug Registration Inspection of Manufacturing Site and Pre-market Good Manufacturing Practice (GMP) Inspection (Trial) 》(attachment5), approved by the National Medical Products Administration, hereby promulgated and will take effects as from January 1, 2022.
It is hereby announced.
Attachment:
1.《Work Procedures for Drug Registration Inspection(Trial)》
