Thinking on Clinical Key Problems During Transformation of Preparations in Medical Institutions to Innovative Chinese Medicines
10.13422/j.cnki.syfjx.20230348
- VernacularTitle:医疗机构制剂向中药创新药转化过程中临床关键问题思考
- Author:
Yao LU
1
;
Lin SHEN
2
;
Yuqiao LU
1
;
Xu CHEN
3
Author Information
1. Dongfang Hospital，Beijing University of Chinese Medicine，Beijing 100078，China
2. Beijing Drug Evaluation and Inspection Center，Beijing 100035，China
3. National Medical Products Administration，Beijing 100038，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine （TCM） preparations in medical institutions;
three-combination evaluation evidence system;
human use experience;
whole life cycle;
randomized controlled trial （RCT）
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2023;29(6):231-236
- CountryChina
- Language:Chinese
-
Abstract:
Under the national policy background of traditional Chinese medicine（TCM）registration review and approval reform， TCM preparations in medical institutions（hereinafter referred to as medical institution preparations） have human use experience， conform to the characteristics of TCM clinical practice， and have advantages in the research and development of innovative Chinese medicines. Therefore， the research and development mode based on clinical experience prescription-medical institution preparations-innovative Chinese medicines has attracted widespread attention from the industry. However， in the process of development and use of medical institution preparations， there are generally clinical problems that restrict their transformation into innovative Chinese medicines， resulting in a relatively weak collection basis of human use experience and insufficient clinical evidence for supporting the research and development of new TCM medicines. In this paper， on the basis of sorting out the supporting regulations and relevant technical requirements of human use experience， and analyzing the clinical problems restricting the transformation of medical institution preparations， it provides suggestions for medical institutions to carry out high-quality research on human use experience of preparations in the process of TCM clinical practice from the aspects of continuously exploring clinical value， improving the construction of information system， focusing on the TCM clinical practice and giving full play to the advantages of discipline cooperation. By realizing the whole life cycle management of medical institution preparations based on three-combination evaluation evidence system， we can promote the transformation of medical institution preparations into innovative Chinese medicines.
