According to the notice of the National Medical Insurance Bureau, this opinion is mainly to thoroughly implement the national standardization strategy and accelerate the formation of a unified national medical security standardization system.
On the afternoon of July 1, the Medical and Health Administration of the National Health and Health Commission issued the "Notice on Printing and Distributing the First Batch of National Key Monitoring and Rational Drugs (Chemicals and Biological Products)".
Injectables change sterilization process application is a more common supplementary application. There are several common changes in the current application materials: change from sterilization filtration process to terminal sterilization process; change residual residual sterilization process to excessive Killing sterilization process; changing from the steam sterilization process to the residual probability method or the overkill sterilization process. According to the “Technical Guidelines for Listed Chemicals Change Research”, the above changes may have a significant impact on the safety, effectiveness and quality controllability of the drug. It is a Class III change and requires comprehensive research and verification.