[Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions].
Zhongguo Zhong Yao Za Zhi
; 47(2): 285-294, 2022 Jan.
Article
in Zh
| MEDLINE
| ID: mdl-35178969
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".
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Drugs, Chinese Herbal
/
Drug-Related Side Effects and Adverse Reactions
Type of study:
Diagnostic_studies
/
Guideline
Limits:
Humans
Country/Region as subject:
Asia
Language:
Zh
Journal:
Zhongguo Zhong Yao Za Zhi
Journal subject:
FARMACOLOGIA
/
TERAPIAS COMPLEMENTARES
Year:
2022
Document type:
Article
Affiliation country:
China