Résumé
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.
Résumé
Because of the complex recipe composition and various clinical applications,research and development new drugs of Chinese materia medica (CMM) should follow the usage in clinical application;focus on the critical quality attribute of the preparations and select the evaluation index for optimizing process parameters reasonably to achieve the aim of improvement of the preparation process and quality of the drug products.
Résumé
The Influence of new medical model on the transformation of traditional Chinese medicine (TCM) compound,the function and principle of Chinese herbal compound,the special consideration on pharmacological evaluation of TCM compound prescription,and the important role of pharmacology evaluation on TCM compound were discussed.