Analysis of innovative drug category 1.2 in traditional Chinese medicine and considerations on quality control of extracts.
10.19540/j.cnki.cjcmm.20201230.301
- Author:
Xiao-Xia ZHAO
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration Beijing 100022, China.
- Publication Type:Journal Article
- Keywords:
European Medicines Agency(EMA);
Food and Drug Administration(FDA);
extract;
innovative drug category 1.2 in traditional Chinese medicine;
quality control
- MeSH:
Drugs, Chinese Herbal;
Herbal Medicine;
Medicine, Chinese Traditional;
Pharmaceutical Preparations;
Plant Extracts;
Quality Control
- From:
China Journal of Chinese Materia Medica
2021;46(10):2601-2606
- CountryChina
- Language:Chinese
-
Abstract:
In this article, the essence of innovative drug category 1.2 extracts and preparations in the new version of the New Drug Registration Category of traditional Chinese medicines(TCM) was analyzed by combing through the history of provisions on drug registration and comparing with other categories of drugs. After analyzing the characteristics of this type of preparations, the author concluded that the quality control objectives of category 1.2 extract should focus on ensuring the quality consistency of the active ingredients/components in batches, so as to guarantee the consistency of drug quality and efficacy. With reference to the relevant technical requirements for herbal medicinal products in European Medicines Agency(EMA) and botanicals in Food and Drug Administration(FDA),the key points in quality control of the extract should include the content and composition of the therapeutic constituents, the type and content of the concomitants, and the influence of exogenous contaminants on drug safety.
