Evaluation on review quality management and progress and suggestions of reform in traditional Chinese medicine review.
10.19540/j.cnki.cjcmm.20210416.501
- Author:
Na AN
1
;
Ling HAN
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration Beijing 100022, China.
- Publication Type:Journal Article
- Keywords:
drug reform;
drug review;
quality management;
traditional Chinese medicine(TCM)
- MeSH:
Drugs, Chinese Herbal;
Medicine, Chinese Traditional;
Quality Control;
Reference Standards
- From:
China Journal of Chinese Materia Medica
2021;46(22):5999-6003
- CountryChina
- Language:Chinese
-
Abstract:
Efficient management and evaluation is the primary responsibility of drug regulatory authorities in various countries, whose management services are mainly delivered in accordance with the Good Review Practices(GRPs) and ISO 9001 quality management system. In 2015, Opinions on Reforming the Evaluation and Approval System of Drugs and Medical Devices included the perfection of quality control review system as the content of reform in drug review and approval. On this basis, the traditional Chinese medicine(TCM) review authority has shortened the review time, strengthened the communication, offered technical guidelines, designed the review template with guiding significance, and carried out diversified training and performance evaluation, to continuously strengthen the standardization of TCM review and approval and effectively guarantee the scientificity and consistency of new TCMs. However, the current quality management system for TCM review is not yet mature. It is recommended to employ ISO 9001 quality management system to manage the review work, utilize the GRP for better management of the archive files in the review process, and use quality evaluation indicators to improve the review quality management, thereby further perfecting the TCM review management system.
