Analysis of the key implementation points for changes in safety information of marketed drugs in China
Post-marketing changes in safety information are integral to the management of a drug's lifecycle.As China's regulatory system for drug changes gradually improves,there have been significant shifts in post-marketing change manage-ment requirements,particularly focusing on safety information changes,which have garnered increasing attention.When mar-keting authorization holders alter drug safety information,they should consider the nature of the change,the level of risk in-volved,and the implementation requirements.Changes are classified based on their impact and risk on clinical safety and ef-fective use,distinguishing between major,moderate,and minor changes.Supplementary applications,filings,or reports should be made according to the corresponding change procedures.Strengthening clinical communication post-change in drug safety information is essential for effective information transmission.
NETL
NSTL
万方数据
