Analysis of Leaflets’ Revision Announcements and Record Information of Chinese Patent Drugs in 2014-2018

OBJECTIVE To analyze the safety information in leaflets’ revision announcement of Chinese patent drugs, and analyze the current supervisory situation of leaflets’ safety information and the implementation of supervision measures combined with the public record information, so as to provide basis for post-marketing surveillance of Chinese patent drugs. METHODS Making statistics and analysis of safety information by collecting and sorting out the leaflets’ revision announcements of Chinese patent drugs published by National Medical Products Administration in 2014-2018. Then collected the public record information and compared with the requirements of revision announcements. RESULTS The 101 varieties of Chinese patent drugs were collected, 91.09%, 93.07% and 99.01% varieties were respectively involved in revision of “adverse reactions” “contraindications” and “precautions”. The record rates of 36.80% varieties reached 100%, the record rates of 32.80% varieties were 50%-86%, the record rates of 12.00% varieties were 9%-49%, 18.40% varieties had not received any record information. CONCLUSION The regulatory measures of Chinese patent drugs have not been fully implemented. Manufactures should take full responsibility for drug safety, perform duties strictly as requested, control risks and ensure the safety use of drugs.