针对市面上儿童药品缺乏的现状，近日，国家食品药品监督管理局发布《关于深化药品审评审批改革进一步鼓励创新的意见》，将鼓励儿童药物研发。

In view of the situation of children's medicines on the market lack of,In recent days,The state food and drug administration[To further the reform of drug approval review further encourage innovation],Will encourage children to drug development.

　　《意见》重点鼓励具有临床价值的创新药物和临床亟须仿制药以及儿童药物优先审评。将鼓励研发儿童专用剂型和规格，对立题依据充分且具有临床试验数据支持的注册申请，给予加快审评。药监部门将会同有关部门研究在招标、定价、医保等方面鼓励儿童用药研发的综合措施。《意见》还要求健全儿童用药管理的相关制度，完善儿童临床用药规范，鼓励企业积极完善说明书中儿童用药信息。同时，加强儿童用药不良反应监测和再评价，加大对儿童用药安全宣传，积极向医师和患儿家长普及儿童用药知识。

[opinion]Focus on encouraging has the clinical value of innovative drugs and clinical key in generic drugs and medicines for children priority review.Will encourage the development of children special types and specifications,Opposite the topic on the basis of fully and has an application for registration of clinical trial data to support,To speed up the review.The agency will jointly with the related departments to study in the tender/pricing/Health care aspect and so on to encourage children's drugs research and development of comprehensive measures.[opinion]Also requires a sound system of children's drugs management related,Improve children's clinical application specifications,Encourage enterprises to actively improve the instruction information in children's drugs.At the same time,Strengthen children's medicine adverse reaction monitoring and evaluation again,For children's medication safety propaganda,Actively to doctors and parents to popularize knowledge of children's drugs.

　　国家食药监局药品注册司司长王立丰介绍，儿童用药缺的不是品种，而是规格和制剂。因为儿童用药不同于成人用药，有自己的特殊性。成人有耐受性，但小孩喝药比较困难，在制作药品时要做成水果味、甜味、糖浆状等，使得药物更容易送达。儿童器官未发育成熟，身体代谢比成人慢，儿童用药也要考虑这方面因素。国家食药监局鼓励企业在现有制剂基础上，开发适用于儿童不同阶段的用药，鼓励临床单位承担起儿童用药的研究，促进儿童用药发展。(记者 任敏)

National food the drug registration division of China's food and drug administration Wang Lifeng is introduced,Children's drugs lacks of varieties,But specifications and preparation.Because children's drugs is different from the adult dosage,Has its own particularity.Adults have a tolerance,But the child is difficult to drink medicine,When making drugs to make fruit/The sweet/Syrup etc,Making drugs are more likely to reach.Immature child organ,Body metabolism slower than adults,Children's drugs also want to consider the factors.National food drug administration encourage enterprises on the basis of the existing preparation,Various stages of drug development is suitable for the children,Encouraging clinical unit to undertake the study of children's drugs,Promote the development of children's drugs.(The reporter Ren Min)