Policy Support and Project Considerations for Pediatric Drug Development in China

Zhou Ping; Jin Yonghua; Li Chao

doi:10.13407/j.cnki.jpp.1672-108X.2024.01.008

您当前的位置：

首页 >

文章列表页 >

Policy Support and Project Considerations for Pediatric Drug Development in China

更新时间：2024-01-12

- Policy Support and Project Considerations for Pediatric Drug Development in China
- Vol. 30, Issue 1, Pages: 27-32(2024)
- 作者机构：
  
  江苏开元药业有限公司,南京,210000
- 作者简介：
- 基金信息：
- DOI：10.13407/j.cnki.jpp.1672-108X.2024.01.008
  CLC：
- Published：2024，
扫描看全文
Zhou Ping, Jin Yonghua, Li Chao. Policy Support and Project Considerations for Pediatric Drug Development in China. [J]. 30(1):27-32(2024)
DOI：

Zhou Ping, Jin Yonghua, Li Chao. Policy Support and Project Considerations for Pediatric Drug Development in China. [J]. 30(1):27-32(2024) DOI： 10.13407/j.cnki.jpp.1672-108X.2024.01.008.

摘要

我国儿童用药现存问题突出

表现为儿童适宜品种少、适宜剂型和规格缺乏、超说明书用药。近年来

我国药品监管机构发布了多项儿童药物研发的支持政策和指导原则

企业研发热情逐渐增加。本文梳理了国内儿童药物研发的相关配套政策

并尝试从企业的角度提出儿童药物立项的方向

分析研发立项中需要关注的问题。

Abstract

Objective: The current issues in children’s medication are prominent in China

characterized by a limited variety of suitable drugs

a lack of appropriate dosage forms and specifications for children

and off-label drug use. In recent years

drug regulatory authorities have issued multiple support policies and guiding principles for pediatric drug development in China

leading to an increasing enthusiasm for research and development among enterprises. This article reviews the relevant supporting policies for domestic pediatric drug development

attempts to propose directions for the initiation of pediatric drug projects from the perspective of enterprises

and analyzes the issues that need attention in research and development initiation.

关键词

儿童药品研发政策

Keywords

childrendrug developmentpolicy

references

查看原文

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Analysis of 36 Cases of Drug Poisoning in Children in a Grade III, Level A General Hospital andConsideration on Pharmaceutical Care

Application of Dexmedetomidine Combined with Hydromorphone Nasal Drip in Sedation of Mother-InfantSeparation before Adenoidectomy

Sirolimus in the Treatment of 5 Cases of Blue Rubber Bleb Nevus Syndrome in Children and Literature Review

Systematic Review on Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metabolic Disordersin Children

Drug Utilization Evaluation of Voriconazole for Injection in Children Based on Weighted Technique for Order Preference by Similarity to Ideal Solution Method

Related Author

Wang Peng

Xu Ying

Zhang Xiaoming

Zhang Shaonan

Li Changsong

Li Yunxiang

Li Xiaojing

Sun Canlin

Related Institution

The Second People’ s Hospital of Anhui Wuhu, Anhui Wuhu

Jiangsu Taizhou People’s Hospital, Jiangsu Taizhou

Children’s Hospital Affiliated to Zhengzhou University,Henan Children’s Hospital, Zhengzhou Children’s Hospital, Zhengzhou Key Laboratory of Children’s Digestive Diseases

Kunming Children’s Hospital / Children’s Hospital of Kunming Medical University, Kunming

Kunming MedicalUniversity, Kunming

⁰