Since the promulgation of the "Opinions on Reforming the Approval System of Reform Drugs and Medical Devices"，Principles of various technical guidance、Draft for comments、Policy interpretation densely introduced，Nothing to affect the nerves of pharmaceutical companies。

 

  On May 23, the 9th DIA China Annual Conference China National Food and Drug Administration is specially held，The reform of the reform and approval system of the most concerned about the industry at present、Evaluation of the consistency evaluation of generic drugs、Checking of clinical trial data verification and other issues，CFDA related guests brought the latest interpretation。

 

  Review reform around & ldquo; quality、Efficiency、Encouragement、Transparent & rdquo;

 

  Li Jinju, deputy director of CFDA Drug Cosmetics Registration Management Department

 

  After the "Opinions on Reforming the Approval System for Reforming the Reform of the Medical Device Review and Approval"，A series of supporting documents have been introduced one after another，Summary is quality、Efficiency、Encouragement and transparent eight words。

 

  Improve quality。Evaluation of consistency on the drugs that have been listed，New registration classification of unlisted drugs，Establish the concept of reviewing the same level as the international advanced level，Lay the foundation for integration with international。

 

  Improve efficiency。Add reviewers，Establish a communication mechanism，Improve the approval system，Promote BE test filing management，Implementation of medicines and bags、Accessories associated review。

 

  Encourage innovation。Pilot Pilot System of Pharmaceutical Licenses，Implement the priority My stake betting appreview approval，Check the clinical trial data verification。

 

  Public transparency。Strengthen the information disclosure mechanism，Start electronic technology document ECTD construction。Under the background of strict implementation of the "Administrative Measures for Drug Registration"，Guide the R & D declaration data requirements of the enterprise through the secondary file。

 

  Drug registration application is to complete product safety by regulatory authorities and enterprises、Effective、Controlled quality，Guidance specifications are first，Communication in China，Approval Decisions Later。For an enterprise，Quality is the foundation of survival，Innovation is the road to development，R & D and innovation is a process of hard work，Requires scientific and rigorous spirit。We hope to deepen the reform system，Let the new drug research and development of the new level，Make more Chinese people use new drugs in the world early。

 

  Reference preparation filing non -289 catalog more varieties more

 

  China Food and Drug Inspection Research Institute's imitation drug consistency evaluation office Xiaohong Street

 

  Currently more problems encountered in the consistency evaluation of generic drugs in the industry，Among them, the reference preparation has become the core focus，According to enterprise feedback，Disputes of reference preparations are mainly concentrated in difficult reference preparations、The acquisition of the reference preparation、Whether the real estateization of the original pharmaceutical drug can be used as the problem of these reunification preparations。

 

  As of May 18，We received a total of 5,321 preparation preparation cases，Jiangsu、Shandong、Shanghai、Zhejiang、The top pharmaceutical provinces such as Guangdong are among the best，Among the 289 varieties that must be completed by the end of 2018, the number of records of 289 varieties must be 2882 cases，Reference preparation records that the number of 289 varieties in non -289 varieties is far more than 289 varieties。

 

  Among the 289 varieties that must be evaluated by the end of 2018，232 varieties have already been recorded，There is no main reason for the variety of varieties: some varieties are old varieties in the 12th version of the medicine directory，There are not many sales on the market，Enterprise development enthusiasm for development with small sales volume is low，or the original research medicine cannot be found，There are also special domestic varieties。

 

  According to the data display of the equivalent of the CDE chemical generic generic drug biological stake sports betting appequivalent and clinical trial filing information platform，At present, 78 pieces of newly declared chemical generic drug BE filing，Consistency Evaluation BE record 85 cases，The clinical equivalent test that has not yet been successfully recorded。

 

  Questions on the shortage of BE test resources，The recently promulgated clinical trial reform policy has been reflected，Including the qualifications of clinical trial institutions from identification to record, etc.。At present, we have collected and summarized the issues related to the industry's reference preparations and clinical resources reflected in the relevant departments，After that, experts will be organized to conduct research and discussion，You can continue to pay attention to the latest progress。

 

  Gradually realize the review of various registered applications on a time limit

 

  CFDA Drug Review Center Business Management Office Huang Qingzhu

 

  In order to further implement the reform of the drug review and evaluation system，Solve the backlog of drugs，We mainly focus on the following five items in terms of institutional construction:

 

  Adaptive team review system。Set up review organizations according to indications，Forms the clinical reviewer as the core，Pharmacology、Toxic、Pharmacy，Statistics and other professional reviewers and project managers jointly composed of the review team。Multi -professional review，Comprehensive evaluation and collective decision，Determine the rights and responsibilities of the master and reviewer，Posted by different levels of reviewers authorized according to risk authorization。Strengthen the construction of professional disciplines for each review。

 

  Establish a team manager team。Responsible for organizing and coordinating drug review work，Coordination internal and external，Serving the review team and applicant。Reviewers focus on technical review，Project manager focuses on coordination and communication。Improve review organization and communication efficiency，Give play to supervision and integrity & ldquo; Firewall & rdquo;。

 

  Preferred review。Implementation of innovative drugs with clinical value and urgently needed generic drugs that are urgently needed for clinical value，Accelerate the listing of approved products，As of now, 261 applications have been included in the preferred review。In the future, consider the normalization of the backlog on the basis of gradually solving the backlog。

 

  communication system。Published the "Administrative Measures for Drug R & D and Technical Review and Communication and Communication (Trial)，Stake Sports BettingFocus on solving the problem of difficult problems and technical guidelines that the applicant is not covered。Strengthen the exchange of R & D and review，For innovative drugs，The R & D and evaluation of clinical urgent need of drugs provides technical support。Establish a general technical problem consultation work system，Timely、Accurate feedback consultation Question，Improve the quality and efficiency of consulting work。

 

  System of the Expert Consultation Committee。Ensuring the scientific justice of drug approval，Improve the transparency of drug review，Improve the review quality control system。

 

  In the next step, we will gradually realize the review of various registered applications on a time limit，Make sure that new backlogs will not produce through various reform measures to implement various reform measures，By 2020, build a 1,600 person's professional complete、Reasonable configuration、A review team and approval system that meets the needs of public medication and industrial development needs。

 

  Data Check the most common problem in the test process records and test data traceability

 

  CFDA Food and Drug Review and Inspection Center Deputy Director Dong Jiangping

 

  Depending on & ldquo; Four the most stringent & rdquo; requirements，The State Administration of General Administration has organized the verification of drug clinical trial data，As of May 2017，Inspection Center incorporates a total of 1989 varieties into inspection tasks，284 varieties have been checked，1204 varieties withdrawn。Clinical trial verification mainly focuses on two aspects of clinical and biological sample analysis，The most found problem is the traceability of the clinical trial process records and test data，Type of nearly 30%of the overall problem，Others also include test drug management and records、Analysis results trace the source、Biological sample detection, etc.。

 

  Next Food and Drug Review and Inspection Center will increase the intensity and progress of the verification of clinical trial data，According to the work plan，Li Bao completed the drug clinical trial data inspection of the drug clinical trial data required by the Party Group of the State Food and Drug Administration of the State Food and Drugs of the Communist Party of China in the end of June 2017。Further improve the inspection work procedure，Formation of Refine Checking Plan，Check the requirements for writing report，Strengthen the management of the review committee，Improve communication meeting mechanism。Improve the technical standards of on -site inspection，Insession stake online sports bettingwith international standards，Improve the quality of on -site inspection，Unified check the scale。Keep an open and transparent work style，Accept the supervision of the data verification work of all parties，Strengthen information disclosure work，Expand the public content and scope，Improve the quality of information disclosure。

 

  In the field of drug production and circulation，2016 Food and Drug Audit and Inspection Center inspection involved 431 varieties，A total of 1277 inspectors are sent，Covering the quality of drug quality production、GMP certification check、GMP tracking check、Drug Flight Examination、Imported drugs overseas production site inspection、Seven types of inspections such as drug circulation inspection。

 

  2017 Food and Drug Review and Inspection Center will increase team building intensity，Improve relevant regulations，Set the bottom line of behavior，Let the inspection be based on，Joining drug research and development with the industry、Production、circulation、Using environment purification，On the other hand, strengthen communication and exchange with foreign industry experts，Improve industry standards，Further promote the legalization of the verification work、Scientific、standardization、Internationalization。