Wu Yan, deputy director of the State Food and Drug Administration Wu Yan, delivered a speech at the 8th China Pharmaceutical Entrepreneur Annual Conference and 2016 & rsquo;，Content contains the drug review speed of the industry、Improve drug review standards and quality、Consistency of the quality and efficacy of drugs、Clinical data check、Production process check、Rectification in the field of circulation。

 

  Accelerate the speed of drug review

 

  The current drug review speed is slow，It has affected the speed of innovation。August 2015，Documents No. 44 of the State Council set 5 targets、12 tasks，4 guarantee measures。5 of the project standard is to speed up review and approval，Requirements to basically eliminate backlogs in 2016，To 2018 to achieve a time -limited review。

 

  2015 Drug Review Center (CDE) completed about 10,000 reviews and approval，Back pressure 23,000 pieces，It is expected to complete 12,000 pieces at the end of this year，It is expected to have a backlog of 9,000 pieces，Basically realized eliminate backlog。It is expected to achieve annual approval in and out of 2017，2018 strive to achieve approval on time limit。

 

  Completion of time limit approval must be solved: one is to increase reviewers; the other is to control the application volume。CDE can be transferred to the Provincial Bureau、Borrowing an expert、Social recruitment and other ways to increase reviewers。On the other hand，CDE controls a certain amount of acceptance by increasing the threshold。In order to increase the speed of approval，CDE will reform approval process、Optimized review procedure、Simplified review process，Stand on the regulation of Document 44。

 

  Improve the standards and quality of the review

 

  No. 44 Documents 5 Project standards to improve the quality of review。CFDA has done a lot of work in the classification of new drugs，Nine categories of chemical drugs to current 5 categories，Adjust the definition of new drugs。The concept of the new medicine is the world'stake online sports bettings stake sports betting appfirst listing，instead of the first domestic listing。The new medicine we need，Not a simple repetition of existing products，Encourage the industry to take the road of innovation。and generic drugs should be done according to the original research requirements，Realizing the substitution of the original research。

 

  Drugs have better positioning during research and development，Let those drugs that really have innovative value get more support and help，Makes generic drugs return to imitation。If the new drug meets the clinical effect、Imitation drugs are consistent with the original research medicine，Implementation alternative，The quality of drugs will be greatly improved。

 

  New definition of the world will be for medicines。Patent、Data protection, etc.，Including guidance files、Technical requirements、New drug patent and data protection。

 

  Consistency of generic drugs

 

  Innovative drugs need to be new，Imitation drugs should be the same，Adapted medicines should be excellent。The consistency evaluation of the quality and efficacy of the medicine after the listing is the most difficult to reform the drug review、The longest -time reform。At the National Health and Health Conference just ended recently，General Secretary Xi Jinping's speech clearly proposed the consistency evaluation of the drug -based drugs; Premier Li Keqiang incorporated the work into the next work requirements during the speech of the conference; Deputy Premier Liu Yandong made it clear that the meeting summarized the meeting. Be sure to do this work、Doing really。"Healthy China 2030"、Medical reform & ldquo; 135 & rdquo; plan、Drugs & ldquo; 13th Five -Year Plan & RDQUO; Planning all write consistency evaluation into the work plan。The upper and lower consensus of this work，I look forward to。

 

  In the evaluation, we mainly pay attention to two points: the acquisition of the reference preparation and the biological equivalent test。Get the reference preparation，High attention is because of the right to choose the right，Through fast。CFDA has received hundreds of varieties of enterprises for reporting，and partial reply。Everyone hopes that the General Administration can introduce the reference preparation directory，Available、optional、Available。The General Administration is organizing a group of experts to formulate relevant regulations，Also requires group strategies。I hope everyone will not wait and rely on。If these drugs have sales，The first rushing as a reference preparation; if there is no sales in China，Everyone has the ability to buy abroad，CFDA is willing to do a good job for everyone。Give play to subjective energy，I can do it first。

 

  The second is the biological equivalent test (BE)。At present, the General Administration has approved thousands of generic drug BE tests。If the consistency evaluation stake sports betting appis stake betting appto be carried out，Maybe there are thousands of BE tests to carry out。But at present only more than 100 clinical institutions allowed to do BE tests at present，How to undertake nearly 10,000 clinical trials? CFDA is also trying to find a way，How to promote clinical medical institutions to actively participate in clinical trials，Maybe I will soon introduce relevant guidance documents。

 

  Clinical data check

 

  The data verification announcement released on July 22, 2015 has produced shocks in China。The positive significance of the verification is beyond doubt，That is to allow those institutions and enterprises that really engage in research and development to get fair treatment and research environment，Let those who do not standardize、Unreal can take the initiative to exit。It is also because of clinical data verification，We have decreased in the number of declarations。But this also brings some misunderstandings、Misunderstanding。

 

  For media reports & ldquo; 80%of Chinese clinical trial data fraud & rdquo;，The General Administration clarified through a spokesman last week。In clinical data verification，Application for the active withdrawal of the company does reached 80%，But some are irregular data，Including data deletion、Modify、Leak filling, etc.，Some are unreal data，We can’t regard all of these actively withdrawal as fake。The General Administration conducts on -site verification of more than 100 varieties，It is found that there are more than a dozen product information unreal，It may even be suspected of fraud，But the proportion is only 10 %。

 

  Active withdrawal of enterprises、Not a product of data fraud，CFDA has issued a notice，You can have several channels that can be reported to by improving information。But the industry may report again、How to prepare information、How to queue up after it comes、How to guarantee the review time and other doubts。Some companies have made many positive suggestions，The General Administration will do in -depth research after listening to the opinions of the company，Reasonable opinions will be absorbed。

 

  Production process check

 

  Checking for process，CFDA just issued a draft for consultation，The purpose is to fix the company，Make those products that have changed the process, do not risk。Our original intention is goodwill，But some companies have misunderstandings。I think，On the one hand, the content of the comments draft is not clear，There is a complete room，On the other hand, the company does not understand。

 

  I want to explain three points: a、The process is the process of manufacturing products，This process must be fixed，Can't change without authorization; two、Process improvement is a process of scientific development，As long as it is better than the original，We must be supported。3、If it is changed, the Stake Sports Bettingquality stake betting appdoes not change the quality，Corporate newspaper reporting; if it affects the quality，It is necessary to supplement the approval approval。Many companies are unwilling to submit to approval，It may be that the application time for supplementation is long，It may not come out for half a year。

 

  Since 2007，CFDA carried out several sub -process verification work，We think the implementation of the process is still good。Of course, some product processes do have such problems，For example, Chinese medicine injection、Multi -sets of divorce preparations, etc.。According to Cultural No. 44, we will evaluate the quality of traditional Chinese medicine injections，Make its quality more stable、Products more effective。Traditional Chinese medicine injection must stabilize the base of the first metad，Stable process。Some companies have achieved fingerprint map、Digital production，These companies must praise。For those companies that have not been done，We want to give them time to improve them，The purpose is to improve the quality of the product。Our supervision must be in the better direction development，Walking with everyone。

 

  Rectification in the field of circulation

 

  CFDA issued a special rectification announcement in the circulation field in May 2016，The reason is that the chaos is clustered in the circulation field，Specific performance: First, there are too many circulation enterprises，The nation's 12,000 wholesale enterprises; the second is that there are too many people engaged in drug sales，National Medical Sales Representative is known as a million army。80%of our country's wholesale volume is concentrated in the top 100 companies。According to market economy rules，Some wholesale companies cannot survive。In fact, these wholesale companies are not only alive，Still live well。This has caused a paradox: the market economy has failed in the field of pharmaceutical wholesale，The excellent person can't be better than，The inferiority cannot be eliminated。

 

  The remediation in the field of circulation mainly grabs both ends: one end to solve the problem of more circulation links，The other end should rectify the legality of the operator。The medical reform team launched a two -vote system this time，Its core point is to shorten the circulation link，Squeeze out some of the water in the middle。Many people in the industry are discussing，Also worried。From the food and drug supervisor，We are unswervingly supporting two -vote，It will also perform their duties in accordance with the requirements of the two -vote system，、Out of the circulation of tickets from the circulation，Let the market clean，The circulation process is simple，Reduce cost，Let the public and the people be affordable。

 

  Of course，Rectification in the field of circulation is not possible，Must reform the whole process，Strengthen stake online sports bettingsupervision。stake sports betting appHere，Production enterprises must also be responsible，Can't stand by，Can't be responsible for not being able to leave the pharmaceutical factory，We want to strengthen the responsibility and responsibility of manufacturers in circulation。In short，The rectification of the circulation process is to work hard for everyone，。

 

  Conclusion

 

  In short，Food and Drug Administration must strengthen reform，To strengthen transparency，More to work together with everyone。Reform is the only way for us to strengthen supervision，Reform is an inevitable requirement for improving the quality of drugs。For more than a year，Understand by colleagues in the industry、Support and cooperate，The reform of the drug review and approval system has made some progress，Also received everyone's recognition，But there is still a lot of gaps from everyone's requirements，It also explains that the reform is far away、Never endless，During the reform, I do n’t treat me、Only compete for the day and night，Must be firm confidence，Unity and collaboration。Entrepreneurs who hope to be here、Scientists and experts in groups，Administrative suggestions for the reform of approval，For the innovation of pharmaceuticals。Through our joint efforts，Further improve the working mechanism to encourage innovation、Create an innovative social atmosphere，Accelerate the review and approval of the good medicine for new drugs，Make the pharmaceutical industry realize the transformation created by Chinese manufacturing to China as soon as possible、The transformation of China's speed to China、The transformation of Chinese products to Chinese brands。 (This article is based on Wu Yan, deputy director of the State Food and Drug Administration, at the 8th Chinese Pharmaceutical Entrepreneur Annual Meeting and 2016 & rsquo;