It discusses the progress of drug regulatory reform and points out the new challenges of drug regulatory professionalism in institutional restructuring and integration after major adjustments in the drug regulatory system；At the same time，it introduces the direction and key points of the revision of the Drug Administration Law，the process of formulating the Vaccine Management Law，and the reform measures concerning the administrative approval of medicines related to the Notice on Rolling Out the Reform “Separating Permits from the Business License” in the country.