The drug review reform launched last August has begun to achieve results。Xu Jiaqi, Director of the Pharmaceutical Review Center of Food and Drug Administration, disclosed to the outside world，As of the end of September 2016，Completed review tasks 8868 pieces，It is 2 times the same period of 2015。The registration application of the backlog has been reduced from nearly 22,000 pieces at the peak of 2015 to the current 11500 pieces。This reform seems to attract the most attention of the pharmaceutical industry，Reality is closely related to people's livelihood。Drug review reform means that ordinary people can use safe and effective & ldquo; new drugs & rdquo;。Actually，The problem of solving the backlog of drug review，It is just a part of the reform storm set off in the past year in the past year。

 

  As of the end of September 2016，Completed review tasks 8868 pieces，It is 2 times the same period of 2015。The registration application of the backlog has been reduced from nearly 22,000 pieces at the peak of 2015 to the current 11500 pieces。

 

  Current，Published 8 batches of drug priority review catalog，greatly optimized the review mode and program。

 

  By the end of this year，Chemical Pharmaceutical Innovation Pharmaceutical Clinical Test Application will be reviewed on a time limit，11,000 pieces of review tasks will be completed throughout the year。

 

  Drug review has a backlog of up to 32,000 pieces

 

  Research on Clinical Test (hereinafter referred to as clinical) is the key link of the development of innovative drugs。Innovative medicine developed by enterprises，Passing I、Ⅱ、Phase III clinical verification of its safety and efficacy，Only apply for listing。Before clinical，The technical review and administrative approval of the Drug Review Center of the State Food and Drug Administration (hereinafter referred to as the Drug Review Center) and the Drug Cosmetics Registration Management Department (hereinafter referred to as the Registration Department) must be。

 

  According to media reports，It takes 18 months in a Chinese innovative drug review and approval，A stake betting appstake online sports bettinggeneric drug has to wait for six or seven years，Far more than 6 months of specified time limit。

 

   & ldquo; The backlog of drug review is a difficult task faced by the State Administration of Food and Drugs & RDQUO;，The Director of the Food and Drug Administration Bi Jingquan went to the National New Office for the first time after taking office.，The highest backlog of Chinese medicine reached more than 32,000 pieces when the highest backlog of drug review。

 

  On the one hand, for the same generic drug，Different pharmaceutical companies apply for registration repeatedly，Leading market vicious competition，Some imitation drug quality is large and there is a large gap between the international advanced level。On the other hand，Some new drugs that are urgently needed in clinical clinical need to be launched，I have to face a huge queuing long dragon，The listing approval time for listing is too long，Activated interests affecting patients。

 

  August last year，Starting for many years of drug review approval reform。The State Council issued the "Opinions on Reforming the Approval System for Reform of the Medical Devices for Medical Devices"，Requires to speed up the review and approval of innovative drugs。

 

  Published 8 batches of drug priority review catalog

 

   & ldquo; Solve the backlog of the review task and encourage innovation.，Xu Jiaqi, Director of the Pharmaceutical Review Center of Food and Drug Administration, disclosed to the outside world，As of the end of September 2016，Completed review tasks 8868 pieces，It is 2 times the same period of 2015。The registration application of the backlog has been reduced from nearly 22,000 pieces at the peak of 2015 to the current 11500 pieces。

 

  Xu Jiaqi said，The drug review center is solving the backlog of registration applications，For innovative medicine、Children's medication、Urgently need medicine for clinical urgent need、Patent Expired Pharmaceuticals and Domestic & LDQUO; first imitation & rdquo;。Current，Published 8 batches of drug priority review catalog，greatly optimized the review mode and program。

 

  Current，Application and supplementary application for clinical trials and supplementary applications of Chinese medicine and biological products has been achieved in a legal time limit。By the end of this year，Chemical Pharmaceutical Innovation Pharmaceutical Clinical Test Application will be reviewed on a time limit，11,000 pieces of review tasks will be completed throughout the year。

 

  The number of people in the drug review center is expected to reach 600 people at the end of the year

 

  The reform goals of the State Council are proposed，Realize the review of various registered applications in 2018，Preliminary formation of a scientific and efficient review system。By 2020, build a professional and complete、Reasonable configuration、A review scientist team that meets the needs of the development of the pharmaceutical industry and the needs of major new drugs。

 

  February this year，Bi Jingquan has helplessly expressed to the outside world，The total number of reviewers of the American Drug Review Center is more than 5,000 people，The actual number of Chinese Pharmaceutical Review stake online sports bettingCenter My stake betting appis more than 130 people，and now the backbone loss is more，The reviewers of the first three years have lost 1/3，The salary income from the company to the company is generally equivalent to 10 times the salary income of the reviewer at the drug review center。

 

  According to Xu Jiaqi，The center has increased the recruitment of reviewers (197 people have been recruited this year)，At the same time, it also introduces international review experts，Establishing the post of chief scientist (Dr. Ruyi, the chief scientist of clinical clinical chief scientists)，Make the review team structure optimized。

 

  It is reported，The number of employees of the drug review center has increased from more than 100 people at the beginning of last year to the current 455 people (including the staff of the provincial bureau)，By the end of this year, the number of employees is expected to reach 600。

 

  The drug review center reviews the latest scientific research results of global high -tech companies，First -class scientists，Especially doctors with rich experience，The review of the new drug listing should be dominated。

 

  Xu Jiaqi revealed，Drug Examination Center sets up the review organization，Forms a clinical reviewer as the core，Pharmacology、Toxicology、Pharmacy、Statistics and other professional reviewers and project managers jointly composed of review teams; multi -professional review、Comprehensive evaluation and collective decision -making。

 

  Realizing the clinical replacement of generic drugs and original drugs

 

  Bi Jingquan attended the launching ceremony of the National Safety Medicine Month in 2016 and the first China Pharmaceutical Safety Forum，Make sure the quality and efficacy of newly listed drugs，The standards of consistent quality and efficacy & rdquo; standards，Hold up the consistency evaluation of the quality of the quality of the generic drug，Implementation of generic drugs and original drugs can replace each other clinically。

 

  Bi Jingquan's & ldquo; Imitation drugs and original research drugs can replace each other & rdquo;，In fact, it is knocking over the lack of clinical verification in the past，Some biological equivalent has not been verified，Some enterprises clinical trial data fake，& ldquo; Qualified invalid pills & rdquo;。

 

  Past，The pharmaceutical supervision department approved the compulsory requirements of the consistency evaluation of the original drug quality efficacy，Therefore, there are some gaps with some drugs in terms of efficacy with the original drug。The gap approved by the listing before 2007 is greater。

 

  A staff member of a drug supervision department also told Nandu reporters，Take a medicine and take medicine to take a piece of medicine and take effect，Domestic drugs need to stake online sports bettingtake stake betting app4 tablets before using。& ldquo; The basic principles of drug listing are safe and effective，If the medicine is invalid，Will be treated with misunderstanding，Waste resources，This is also the biggest unsafe。& rdquo; Bi Jingquan said at the meeting，& ldquo; This is a class that supplements history & rdquo;。

 

  July last year，The State Administration of Food and Drug Administration issued the "Announcement on the Inspection of the Pharmaceutical Clinical Test Data Inspection"，Applicants who have declared and for review at the State Administration，All must be compared with the clinical trial plan，Self -examination of clinical trials of drugs，Make sure the clinical trial data is true、Reliable，Related evidence is stored complete。

 

  February this year，The General Office of the State Council also issued the "Opinions on Promoting the Evaluation of the Consistency of the Quality and Consistent Effects"，Starting industry storm，& ldquo; I have not passed the evaluation within 3 years，Logged out the drug approval number & rdquo;。

 

  Bi Jingquan once said，This company is also a huge challenge，But this work will improve the development quality of the pharmaceutical industry，For truly turning our country's pharmaceutical industry from a large pharmaceutical country to a pharmaceutical country，Really enables the preparation drugs we produce to move towards the international market，All are crucial。

 

  [Extension] "Administrative Measures for the Advisory Committee of Drug Registration Review Experts" will be released soon

 

  Xu Jiaqi revealed，Drug Examination Center learns to learn from the US FDA experience，Based on your own institutional innovation，Exploring and establishing major controversy in drug technology review、Solution mechanism for major difficulties and special technical problems，Clarified the method of publicly demonstrated the solution of disputes，Highlight the open and transparent of review and decision -making。Current，"Administrative Measures for the Advisory Committee of Drug Registration Review Experts" has passed，will be released soon。

 

  In addition，At the level of the drug review center, the "Administrative Measures for the Disclosure of Drug Technology Review Information"，It will be released in the future。Previous，The center has passed the official website to increase acceptance、review process、Disclosure of information such as technical guidelines and review results，Formation of specification guidance before、Communication in China、Review decision -making mode after the scientific review mode，further improved the transparency of the review information，Guide the rational declaration of enterprises，Avoid low -level research、Repeat declaration。

 

  Not standardized for stake sports betting appdrug stake betting appregistration declaration materials、Quality is not high，Multiple replenishment and improvement during the review process，Issues that seriously affect review efficiency，The Drug Examination Center is hurrying to carry out the establishment of the establishment of the volume and the formulation of the "Management Guidelines for the Drug Registration Reporting Information"，Standardize the writing of registration and declaration information、Submission and acceptance，Improve the quality and level of the application of generic drugs in the pharmaceutical industry。