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中国将鼓励儿童药物研制 加强儿童用药管理--亲稳网络舆情监控室
2013-02-27

  中新社北京2月26日电 (记者 欧阳开宇)中国将鼓励儿童药物研制。这是国家食品药品监督管理局26日召开的新闻发布会传递的信息。

China news agency Beijing, feb 26 (Reuters) (The reporter OuYangKaiYu)China will encourage children drug development.This is the state food and drug administration held 26 press conference's message.

  国家食药监局药品注册司司长王立丰当天表示,鼓励研发儿童专用剂型和规格,加强儿童用药管理。

National food the drug registration division of China's food and drug administration Wang Lifeng said the same day,To encourage research and development of children special types and specifications,In order to strengthen the management of children's drugs.

  在中国,儿童药物长期受到药企“冷落”。分析人士指出,由于儿童药物的开发周期较长,利润较低,很多制药企业不选择生产儿童用药。

In China,,Children's medicines by drug companies for a long time"The cold".Analysts pointed out that,Due to the long development cycle of medicines for children,Low profit,Many companies choose not to make children's medicines.

  26日在国家食药监局新闻发布会上公布的《关于深化药品审评审批改革进一步鼓励创新的意见》中,“鼓励研制儿童用药”作为一项措施被单独列出。

26 in national food drug administration announced at a news conference[To further the reform of drug approval review further encourage innovation]In the,"Encourage to develop children's drugs"Is singled out as a measure.

  根据官方新举措,将对立题依据充分且具有临床试验数据支持的儿童药物注册申请,给予加快审评。

According to the official new initiatives,Will be opposing the topic on the basis of full and has a clinical trial data to support children's application for drug registration,To speed up the review.

  “我们在收到申报材料之后,将第一时间对其(儿童用药)进行审评,使儿童用药能够在一个短时间内,在保障安全的前提下,尽快上市。”王立丰说。

"We after received the declaration material,Will be the first time for it(Medicine for children)In the review,Make children's drugs can in a short period of time,On the premise of safety,Listed as soon as possible."Wang Lifeng said.

  王立丰透露,国家食药监局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。

Wang Lifeng revealed,National food drug administration will work with 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.

  中国官方还将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,加强儿童用药不良反应监测和再评价。

Chinese officials will also improve children's drugs management system,Improve children's clinical application specifications,Encourage enterprises to actively improve the instruction information in children's drugs,Strengthen children's medicine adverse reaction monitoring and evaluation again.

  值得一提的是,在26日下发的意见中,官方还明确表示,鼓励国内企业开展境外注册。

It is worth mentioning,In 26, issued opinions,Officials have made it clear,Encourage domestic enterprises to carry out the overseas registered.

  意见指出,支持国内制药企业参与国际竞争,按照国际标准研发产品,开展产品相关的国际认证。对于国内企业在境内外同步开展研发和注册的,接受其提交的境外试验资料。鼓励支持中药境外注册申请。

Opinion points out,Support domestic pharmaceutical enterprises to participate in international competition,In accordance with international standards of research and development products,Conduct of the relevant international product certification.Overseas synchronization to carry out research and development for domestic enterprises in China and registered,Accept the overseas test data submitted.Encourage support for traditional Chinese medicine overseas registration.


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