November 12,The official announcement of the information of the Guangdong Food and Drug Administration announced,The National Food and Drug Administration (hereinafter referred to as & ldquo; the State Food and Drug Administration & rdquo;) has recently made approval on the reform of the drug review and approval mechanism of the drug review (hereinafter referred to as & ldquo; approval & rdquo;)。

    According to the content of the approval,The pilot of the reform will include the State Food and Drug Administration and the Guangdong Provincial Pharmaceutical Review Agency,Authorized the Guangdong Food and Drug Administration for transfer of new drug technology in the administrative area、Drug production technology transfer and some cross -provincial drug entrusted production business for stake online sports bettingtechnical stake online sports bettingreview and administrative approval。

    & ldquo; The current status of drug approval in my country is slower speed,Low efficiency。& rdquo; Yu Mingde, president of the Chinese Medical Enterprise Management Association,& ldquo; There are two ways to solve this problem,One is an increase in the national drug review agency,The other is to delay power,Decentralization to reduce things。& rdquo;

    You can see from approval,The State Food and Drug Administration will transfer technology、Entrusted the production of two approval rights to the local Food and Drug Administration。That is to say,Guangdong pilot adopts the idea of ​​power decentralization。

    Two approval rights decentralized

    Long -term,The length of the approval cycle troubles the development of my country's pharmaceutical industry。& ldquo;,But the number of personnel is too small。& rdquo; Yu Mingde said。Public data display,The number of people at the National Pharmaceutical Review Center in my country is 120 people,The number of personnel in the corresponding institution in the United States is around 2,000。

    Scarce of reviewers,Caused a long queuing time that it takes a long queue in the review stage。In the context of accelerating development of my country's pharmaceutical industry,This problem looks particularly prominent。

    Yu Mingde believes,There are two ways to solve this problem: increase staff and decentralization。But because the additional staff involves the management of state personnel,More complicated; and from the perspective of decentralization,The National Bureau can completely put some approval rights to the place。

    The approval of the State Food and Drug Administration,Put it to the place under stake sports betting appstake betting apptwo approval rights,The new drug technology transfer application and pharmaceutical production technology transfer application proposed by drug manufacturers in Guangdong Province,and the trustee's drug commission application for drug production enterprises in the administrative area of ​​Guangdong Province。

    The State Food and Drug Administration authorized the Guangdong Food and Drug Administration to approve the above two applications,Approval conclusion is reported to the National Bureau for filing。

    & ldquo; The risk of these two approval items is lower、Technical operation is not complicated,The local drug supervision department has the ability to bear,This also reduces the burden of approval from the National Bureau。& rdquo; Hu Yinglian said,& ldquo; And,For the pharmaceutical industry,This may also improve the utilization efficiency of the drug approval number。& rdquo;

    Guangdong take the lead pilot

    The State Food and Drug Administration said in the annual report of drug registration approval in 2011,my country will gradually establish a management model combined with the combination of centralized review and regional pharmaceutical review center for centralized review and national control。

    The report said that the right to register the drug registration management,& ldquo; Reasonable divide the central and local,Administrative approval and technical review rights,Make full use of the human resources and technical capabilities of the Provincial Bureau,Authorized Provincial Bureau with qualifications and conditions to undertake the review and approval of some drug registration applications。& rdquo;

    Guangdong as the first pilot of this reform,Is My stake betting appStake Sports Bettingmy country ’s major pharmaceutical province。According to statistics from the Guangdong Food and Drug Administration,A total of 30 (times) pharmaceutical manufacturers in Guangdong Province have been commissioned by foreign provinces in the past three years、Production of about 160 medicines for products。and pilot to spend Guangzhou,Another important background is the approval of the State Council about the development of Hengqin Island。

    The State Council proposed in the approval of Hengqin Island,Supporting Hengqin Traditional Chinese Medicine Industrial Park to carry out research on Chinese medicine innovation,Support Guangdong Province to conduct a first trial in the reform of the drug supervision mechanism。

    March this year,The Guangdong Provincial Government and the State Food and Drug Administration signed a memorandum of cooperation in the pioneering zone of Guangdong Food and Drug Safety Supervision。In the next three years,Both parties will build a working mechanism for co -construction、Strengthening the construction of food and drug supervision technology support system、Strengthening the construction of food and drug supervision capabilities。

    Guangdong Food and Drug Administration believes,The decentralization of technical transfer approval will significantly shorten the time for review and approval,Accelerated the landing of the new drug project in Guangdong Province; and commissioned production to authorize Guangdong for approval,It is conducive to improving the efficiency of the use of drug production capacity in Guangdong Province,Promoting the concentration and quality stake betting appof the pharmaceutical stake betting appindustry in Guangdong Province。