Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions.
10.19540/j.cnki.cjcmm.20211117.501
- Author:
Bing ZHANG
1
;
Xiao-Meng ZHANG
1
;
Zhi-Jian LIN
1
;
Ri-Na SA
1
;
Jin-Tao LYU
1
;
Hao WU
1
;
Yao-Lei LI
1
;
Hui-Zhe XU
1
;
Zheng-Kai HUANG
1
;
Yu-Bo GUO
2
;
Xiang-Fei SU
3
;
Xiao-Jiao DUAN
3
Author Information
1. School of Chinese Materia Medica,Beijing University of Chinese Medicine Beijing 102488,China Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,Beijing University of Chinese Medicine Beijing 102488,China.
2. National Museum of Traditional Chinese Medicine Beijing 100027,China.
3. Standardization Office of Chinese Association of Chinese Medicine Beijing 100029,China.
- Publication Type:Journal Article
- Keywords:
Chinese patent medicine instruction;
group standard;
revision;
safety information;
technical specification
- MeSH:
China;
Drug-Related Side Effects and Adverse Reactions;
Drugs, Chinese Herbal/adverse effects*;
Humans;
Medicine, Chinese Traditional;
Nonprescription Drugs/adverse effects*;
Reference Standards
- From:
China Journal of Chinese Materia Medica
2022;47(2):285-294
- CountryChina
- Language:Chinese
-
Abstract:
Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".
