Reflections on supervision strategies of new Tibetan drug registration.
10.19540/j.cnki.cjcmm.20220627.601
- Author:
Dan LIANG
1
;
Tsring PEMBA
2
;
Jiang-Yong YU
3
;
Jian-Yuan TANG
1
;
Yue-Hua ZHOU
4
;
Hua HUA
5
;
Wei-Wu CHEN
2
;
Yan-Ling AI
1
;
Gang ZHOU
4
;
Lei ZHANG
6
;
Ting WANG
7
;
Yong-Wen ZHANG
8
;
Chong ZOU
9
;
Wei-Xiong LIANG
10
;
Jie-Lai XIA
11
;
Nai-Qing ZHAO
12
;
Xiao-Bo SUN
13
;
Wei WEI
14
;
Bao-He WANG
15
;
Hong DING
1
;
Guo-Chen WANG
16
;
Tsring PUQIONG
17
;
Phuntsok KELSNG
17
;
Guo-Qiang WANG
16
Author Information
1. Hospital of Chengdu University of Traditional Chinese Medicine Chengdu 610075, China.
2. Tibet Yuzheng Health Technology Co., Ltd. Lhasa 850000, China.
3. National Medical Products Administration Beijing 100037, China.
4. Center for Drug Evaluation,NMPA Beijing 100022, China.
5. Institute of Translational Pharmacology and Clinical Application, Sichuan Academy of Chinese Medical Sciences, Sichuan Institute for Translational Chinese Medicine, Sichuan Engineering Research Center for Authentic Medicine System Development, Sichuan Engineering Research Center for Authentic Medicine Formation Principle and Quality Evaluation, State Administration of Traditional Chinese Medicine Key Laboratory of Biological Evaluation of Traditional Chinese Medicine Quality Chengdu 610041, China.
6. Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
7. Beijing University of Chinese Medicine Beijing 100029, China.
8. Nanjing University of Chinese Medicine Nanjing 210023, China.
9. Jiangsu Province Hospital of Chinese Medicine Nanjing 210004, China.
10. Guangdong Provincial Hospital of Chinese Medicine Guangzhou 510120, China.
11. Air Force Medical University Xi'an 710038, China.
12. Fudan University Shanghai 200433, China.
13. Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences Beijing 100094, China.
14. Wangjing Hospital of China Academy of Chinese Medical Sciences Beijing 100102, China.
15. Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300150, China.
16. China Association of Chinese Medicine Beijing 100029, China.
17. Tibetan Medicine Hospital of Tibet Autonomous Region Lhasa 850002, China.
- Publication Type:Journal Article
- Keywords:
Tibetan drug;
drug registration;
hospital preparation;
human use experience;
supervision
- MeSH:
Tibet;
Medicine, Tibetan Traditional;
Quality Control;
Pharmaceutical Research;
Drug Industry
- From:
China Journal of Chinese Materia Medica
2022;47(19):5383-5388
- CountryChina
- Language:Chinese
-
Abstract:
Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.
