Development trend of Chinese materia medica products in China: An analysis of CFDA-approved Chinese materia medica (2011-2015)
10.7501/j.issn.0253-2670.2017.06.034
- Author:
Qi-Rui SONG
1
Author Information
1. Institute of Chinese Medical Sciences of University of Macau
- Publication Type:Journal Article
- Keywords:
China Food and Drug Administration;
Chinese materia medica;
Dosage form;
Registration application;
Registration categories;
Therapeutic area
- From:
Chinese Traditional and Herbal Drugs
2017;48(6):1262-1266
- CountryChina
- Language:Chinese
-
Abstract:
To explore the innovation trend of Chinese materia medica (CMM) and provide reference for domestic research and development workers, we sorted out the drugs of CMM approved by China Food and Drug Administration (CFDA) during 2011-2015 through database retrieval, analyzed their drug categories, components, dosage forms, and therapeutic areas, and there were 176 approved CMM registration applications. Among all the 176 approved CMM registration applications, only two approved in class 3, and class 5 has 10, class 6 has 42, and others are three additional CMM categories of class 7-9. There are more compound preparations than on single preparations, and components focus on several key herbs such as Bupleurum and Salvia. Nine dosage forms are mostly focus on capsules and tablets. Therapeutic areas are focus on diseases of genitourinary system and circulatory system. It concludes that innovation of CMM needs to combine CMM theory, learn from modern research and development production technology, and focus on the urogenital system and other areas of increasing demand, and CFDA should also improve the efficiency of the review.
