This paper

taking the formulation of national drug standards for traditional Chinese medicine (TCM) dispensing granules as a case study

explores the improvement of the formation mechanism of national drug standards

and promotes the reform of streamline administration

delegate powers

and improve regulation and services of national standards management

so as to release the vitality of the research and development of standards of drug manufacturers. After nearly two decades of pilot production of TCM dispensing granules

a large number of researches and discussions have been conducted on the formulation of unified standards of TCM dispensing granules from manufacturing enterprises to national standard administration departments

it was found that this work was difficult on the basis of the original drug standard formation mechanism. The authors tried to improve and innovate the formation mechanism of national drug standards

to provide methods and ideas for the formulation and unification of national standards for TCM dispensing granules

and to provide references for the formulation of other national drug standards.