Technical specifications for hospital-based intensive monitoring of post-marketing Chinese patent medicine.
10.19540/j.cnki.cjcmm.20190509.504
- Author:
Yan-Ming XIE
1
;
Xing LIAO
1
;
Jun-Jie JIANG
1
;
Yun-Ling ZHANG
2
;
Rong MA
3
;
Ming-Jun ZHU
4
;
Si-Yan ZHAN
5
;
Jian-Ping LIU
6
;
Jian LIU
7
;
Ze-Huai WEN
8
;
Zhong-Qi YANG
9
;
Yan HE
10
;
Xue-Lin LI
4
Author Information
1. Centre for Evidence-Based Traditional Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences Beijing 100700,China.
2. Xiyuan Hospital,China Academy of Chinese Medical Sciences Beijing 100091,China.
3. the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300193,China.
4. the First Affiliated Hospital of Henan University of Traditional Chinese Medicine Zhengzhou 450000,China.
5. the Center of Evidence-Based Medicine of Peking University Beijing 100191,China.
6. the Center of Evidence-Based Medicine of Beijing University of Chinese Medicine Beijing 100900,China.
7. the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine Hefei 230031,China.
8. Institute of Clinical Pharmacology of Guangdong Hospital of Traditional Chinese Medicine Guangzhou 510000,China.
9. the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine Guangzhou 510400,China.
10. the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Chengdu 610075,China.
- Publication Type:Journal Article
- Keywords:
Chinese patent medicine;
Chinese patent medicine postmarketing safety evaluating;
hospital-based intensive monitoring;
standards;
technical specifications
- MeSH:
Adverse Drug Reaction Reporting Systems;
China;
Hospitals;
Medicine, Chinese Traditional;
Nonprescription Drugs;
Product Surveillance, Postmarketing
- From:
China Journal of Chinese Materia Medica
2019;44(14):2896-2901
- CountryChina
- Language:Chinese
-
Abstract:
In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.
