Considerations of pharmaceutical research for new drugs of Chinese materia medica / 中草药

A series of policies to encourage innovative drug were issued and implemented in opinions of speeding up new drug review and approval by National Medical Products Administration, including application for drug clinical trials on 60 days of implied permission and the communication mechanism. In this article, we analyzed the adjustment of new drug review, and explained the necessity and difference in pharmaceutical research and development of Chinese materia medica (CMM), and illuminated the main problems and emphases in CMM pharmaceutical research in aspects of source of medicinal materials, production process, quality research and standards, expecting to provide reference for speeding up new drug review and benefit drug applicants.

Development trend of Chinese materia medica products in China: An analysis of CFDA-approved Chinese materia medica (2011-2015) / 中草药

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.

Insight into recently issued community herbal monograph on Ginkgo biloba L., folium and its impact on registration strategy of Ginkgo Folium products in EU / 中草药

In January, 2014, European Medicines Agency (EMEA) issued a draft for community herbal monograph on Ginkgo biloba L., folium. That means the community herbal monograph on Ginkgo biloba L., folium has been settled finally. This assay introduces the new Ginkgo monograph briefly, describes the two registering methods and requirements for herbal medicines in EU, and reads the new monograph in more detail. By analyzing the impact of the new monograph on Ginkgo Folium products, this monograph will offer a very important reference and basis for the herbal registration application of Ginkgo Folium products in EU.

Pondering on registration of Chinese patent medicine containing national key-protected wild medicinal materials / 中草药

Some laws about the national key-protected wild medicinal materials, their resources and application status are reviewed. Some problems about the management and application of the national key-protected wild medicinal materials are also analyzed. It is suggested that the special technical requirements should be put forward according to the endangered categories, the state, and requirement of resource. The registration of Chinese patent medicine containing the national key-protected wild medicinal materials should be confined strictly for their sustainable utilization.