Considerations of pharmaceutical research for new drugs of Chinese materia medica
10.7501/j.issn.0253-2670.2019.23.031
- Author:
Wei ZHAO
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration
- Publication Type:Journal Article
- Keywords:
New drugs of Chinese materia medica;
Pharmaceutical stage research;
Process design;
Quality standard;
Registration application of Chinese materia medica;
Source of medicinal materials
- From:
Chinese Traditional and Herbal Drugs
2019;50(23):5872-5875
- CountryChina
- Language:Chinese
-
Abstract:
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.
