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State Drug Administration: Accelerate the approval of the listing of overseas new drugs to benefit from Chinese patients as soon as possible
Release time: 2018-07-10 & nbsp & nbsp & nbsp Source: Anonymous

Recently,The State Council Information Office holds a routine briefing of the State Council's policy,Jiao Hong, director of the State Drug Administration, introduced the relevant work of accelerating the review and approval of new drug reviews。Jiao Hong said,Drugs are special products for treating Stake Sports Bettingstake online sports bettingdiseases and saving people,It is related to the vital interests of the people,It is also the most basic problem of people's livelihood。The Pharmaceutical Supervision Bureau conscientiously implements the requirements of the State Council meeting,I have introduced the approval policy of simplified overseas listing of new drugs,Quickly approved a number of new overseas drugs,Accelerate the approval of the review and approval of the new drugs overseas to achieve positive progress。Since the Executive Meeting of the State Council on April 12,The Pharmaceutical Supervision Bureau has carried out the following work。

First, simplify the approval procedures for overseas new drugs。May this year,The Pharmaceutical Supervision Bureau issued the "Announcement on Optimizing Drug Registration Review Approval Related Essays" with the Health and Health Commission,greatly simplifying the approval procedures for overseas new drugs。Drugs that are seriously endangered and have no effective treatment of diseases and rare diseases,At the same time, it is confirmed that there is no human difference,Applicants do not need to apply for clinical trials,Can be reported to the market stake sports betting appStake Sports Bettingdirectly with overseas test data,The time to go on the market will be accelerated for 1-2 years; overseas new drugs that need to be carried out in my country,The registered test in the clinical trial stage is adjusted from one one -piece inspection to the inspection of the review.,Short the preparation time for the company's inspection sample,Accelerate the listing of overseas new drugs。

Second, optimize the approval procedures for clinical trials of drugs。The "Announcement on Adjusting the Approval of the Review of the Clinical Test of Drugs (Trial)" drafted by the Drug Administration (Trial),being soliciting opinions。After the announcement is officially implemented,Clinical trial application is changed from approval system to default system,Within 60 days from the date of acceptance of clinical trials,If the negative or questioned opinion is not received,Applicants can carry out clinical trials in accordance with the submitted plan,Save time cost for enterprises。

Third is to cancel the compulsory inspection of imported chemical drugs one by batches。April this year,The Pharmaceutical Supervision Bureau issued the "Announcement on Relevant Matters Relevant Matters on Inspection of Import stake betting appChemistry stake betting appDrugs",Cancellation of port inspection of imported chemicals,Strengthen the supervision and draw test after the listing。After the policy is implemented,Imported chemicals can be delivered directly to medical institutions after customs clearance、Retail pharmacy,Can shorten the market time in China 2-3 months,Reduce the cost of reducing new overseas drugs to enter the Chinese market。

Jiao Hong said,By taking the above measures,Recently accelerated the approval of 7 overseas new drugs that have seriously or endangered life diseases,Accelerate the effectiveness of the review and approval of overseas drug reviews.。Next step,The Pharmaceutical Supervision Bureau will further implement the deployment of the State Council,Accelerate the approval of clinical urgent drug review,Implement the encouragement of new drug listing policies and measures; strengthen the construction of professional chemical inspectors,Strengthen the supervision of the event,Increase overseas inspection strength,Let the results of international pharmaceutical innovation benefit in my country as soon as possible。