7 1-5 英

2020-10-03 09:36:1404:00 116
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7-1 As the journalist mentioned what if thedrugs have proven effective

we have been in close contact with relevantproducers. I'm sure that putting the interests of the people first. We willwork together better to find effective treatment solutions.

thank you

正如记者所提到的,如果这些药物被证明是有效的话

我们一直密切联系有关生产商。我肯定地说,人民的利益永远是第一位。我们将更好地合作,寻找有效的治疗方案。

谢谢你

7-2 Well thank you for your question. Welllet me touch upon the emergency approval

of new drugs.

Since the outbreak the statenational medical products administrationhas resolutely implemented the decision makings of the central leadership andhas carried out the extraordinary approval of new drugs. First we launched theemergency approval mechanisms in accordance with law and assembled a specialexpert team centering on academicians coming from various scientificdisciplines.

谢谢你的提问。好吧,让我谈谈新药紧急批准。

自疫情爆发以来,国家药品监督管理局坚决贯彻中央领导决策,开展了新药特殊审批工作。首先,我们依法启动突发事件应急审批机制,组建了专项专家组,以院士为核心,包括来自各学科的专家。

 

7-3 and have established the rule of earlyintervene, approval for all cases and making approvalin science-based manner.

Second, we have put a lot of efforts toformulate the technical guiding principles for the R & D of the covid-19drugs and also the requirements for the safety and effectiveness. And we haveworked with R & D institutions to increase the quality and speed of R &D.

Third we put safety and effectiveness firstin the drug R & D.

并且我们确立了规则,像早期干预、对所有病例进行审批、以科学的方式进行审批的规则等等。

其次,我们付出了大量的努力,制定了《新冠肺炎药物的研发技术指导原则》以及对安全性和有效性的要求。我们还与研发机构合作,提高研发的质量和速度。

第三,我们将安全性和有效性放在药物研发的首位。

7-4 and at the same time, we also aredeveloping new approval methods, for those relatively ready drugs, we havecarried out parallel approval examination and screening to ensure that

the drugs can be used as quickly aspossible for the treatment of covid-19.

Now we can see that a number of safe andeffective chemical agents and TCM drugs have been included in the frontlinetreatment plans, including the wide spectrum( broad spectrum) anti-viralchemical medicines and Chinese patent medicines.

与此同时,我们也在开发新的审批方法,对于那些相对现成的药物,我们已经进行了平行审批检查和筛选,以确保这些药物可以尽可能快地用于治疗新冠肺炎病。

现在我们可以看到,大量安全有效的化学药物和中药已经纳入一线治疗计划,包括广谱抗病毒化学药物和中成药。

 

 

 

7-5 as well as medical agents and traditionalChinese medicine remedies that have already turned out to be effective in clinicaltreatment. also ensuring safety bottom line and effectiveness, quality andextraordinary approval, we have given emergency approval to five new drugs forclinical trials and progress is well underway.

for those who have already carried out R& D including new drugs and generic drugs, for those that are used for covid-19,as long as they are included in relevant research projects for covid-19, welaunched the preferential approval for those drugs and make exceptionalarrangements to approve their circulation.

以及药物制剂和中药方法已经证明在临床治疗中有效的。还要确保安全底线和有效性,质量和特别批准,我们已经紧急批准五个新的药物进行临床试验,进展顺利。

对于那些已经开展了研发的,包括新药和仿制药,对于那些用于新冠肺炎的药物,只要他们被列入相关研究项目治疗新冠肺炎的,我们推出了这些药物的优先审批方式,并作出特殊安排,以批准其流通。


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