History, research status, and thinking on management of production process changes of Chinese materia medica preparations / 中草药

ABSTRACT

To analyze the characteristics and reasons of production process changes of Chinese materia medica (CMM) preparations, study the history and research status on production process changes of CMM preparations, and provide reference for the management of production process changes of CMM preparations. It is considered that there is no effective solution for the management of production process changes of CMM preparations in the current status, so manufacturing companies take a wait-and-see attitude toward these changes. It is suggested that we should apply the risk-based approach and more flexible regulation pattern on production process changes to substitute the present regulatory method, at the same time, improve the technical requirements of production process changes according with the preparations characteristics and development of CMM preparations, and encourage marketing authorization holder to carry out research on the quality uniformity of products to manage the production process changes of CMM preparations, thereby promoting more scientific and rational on production process changes and ensuring the uniformity and stability of CMM preparations.