Annual inventory of CFDA: 73 inspection teams conducted data verification on 117 varieties

Source: CFDA official website 2016-11-04 China is a large country of generic drug production After 30 years of rapid development, the pharmaceutical industry has met the people's access to basic medical drugs, but also accompanied by serious product homogeneity, overcapacity, lack of research and development innovation capabilities and other issues In particular, the foundation of new drug research and development in China is weak, and has experienced a disordered and overheated stage A large number of "new drug" registration applications rush to the registration and approval departments driven by market interests As of the beginning of 2015, more than 22000 applications for "new drugs" have been pending approval, arousing many voices of doubt However, in the vortex of public opinion, the General Administration of the state deliberates and studies Countermeasures in the voice of questioning A large country with a population of 1.3 billion once had the first priority to meet the accessibility of basic medical drugs for the common people When the total output value of the pharmaceutical industry broke through 2.8 trillion yuan and grew into the second largest pharmaceutical market in the world, the opportunity for industrial upgrading and transformation of regulatory methods was ripe, and it was urgent to promote the reform of the drug review and approval system On July 22 last year, the General Administration issued the announcement on self inspection and verification of drug clinical trial data, which decided to carry out self inspection and verification of drug clinical trial data for 1622 drug registration applications that have completed clinical trials and formally applied for production or import and are waiting for review in the drug review center After the announcement, the industry was shocked Some enterprise R & D personnel admit that clinical trial data fraud has existed for a long time In the past, the more standardized enterprises suffered losses, while the less standardized enterprises gained profits This time, the general administration seriously investigated and punished the non-conforming enterprises The registration application with untrue data was withdrawn, and the enterprises actively supported it This policy is conducive to regulating enterprise behavior and industry development When "healthy China" becomes the strategy of a big country, as the basis to ensure the safety and effectiveness of drugs on the market, data verification is of far-reaching significance However, the initial days of carrying out the inspection made every comrade in the inspection center feel pressure The high load of work is like tightening the spring for everyone to keep spinning By the end of October, the data verification team was initially established, the key points of verification were completed, and the verification process was clear The State Administration and the verification center successively issued the letter of explanation on matters related to self inspection of drug clinical trial data, the announcement of the State Food and Drug Administration on self inspection of drug clinical trial data (2015 No 169), etc Announcement to promote the smooth implementation of the verification work According to the work arrangement of the General Administration of China, 289 varieties of drug clinical trial data will be verified by June 30, 2017 In order to achieve the work goal, the comrades of the verification center have been running forward, and the results of data verification have gradually emerged: since March this year, the verification center has publicized 7 batches of clinical trial data on-site verification of 185 varieties, of which 23 varieties have been withdrawn, accounting for only 12.4% This is in sharp contrast to the 1622 inspection varieties announced on July 22 last year and 1193 items voluntarily withdrawn by the enterprise after self inspection, accounting for 83% of the total number of self inspection On September 1 this year, the State Administration announced that it has received 82 new applications for registration of drugs that have completed clinical trials and applied for production or import since July 22 of last year The number of drug approval documents applied by enterprises has been greatly reduced, and compared with the number of registration applications in developed countries, it has returned to the normal level The head of the research and verification office of the verification center said that it has become prudent and rational for pharmaceutical enterprises to submit registration applications, and the authenticity of clinical trial data has become the consensus of the industry However, after some media carried out data verification on the General Administration, the understanding of 1622 registration application enterprises' voluntary withdrawal in large areas through self inspection is still biased, and there are many objective reports The head of the verification center pointed out that the media could not simply attribute the voluntary withdrawal of enterprises to data fraud, and there were many reasons for the voluntary withdrawal of enterprises through self inspection Drug research and development costs a lot of time and energy Drug research and development must be scientific and rigorous, not a little false, not to deliberately fake The purpose of data verification is to crack down on data fraud, encourage innovation, create a good environment for fair competition, and ensure the safety and effectiveness of approved drugs As of September 30 this year, the inspection center has organized 587 inspectors to form 73 inspection teams and completed the inspection of 117 registered application varieties 30 registered application varieties with authenticity problems will not be approved The verification involved 220 drug clinical trial institutions and 31 biological sample analysis units Inspectors' footprints cover 25 provinces, autonomous regions and municipalities directly under the central government and 30 cities across the country It has completely reversed the trend of fraud and instant profit in the field of drug research and development in China, and the atmosphere of respecting science and advocating truth is forming The person in charge of the verification center stressed that during the data verification, it was found that some enterprises still have the fluke mentality and commit fraud Typical cases include: making up the information of subjects, changing from male to female; cutting the test sheet, hiding the report time and personnel information, unable to verify the truth; replacing the products already on the market with their own samples; having test data before the instrument is purchased; modifying, selecting, deleting and manufacturing the data Generally speaking, the common problems in the current clinical data verification are that the enterprise registration applicant does not perform its duties, the cro does not take responsibility, the drug clinical trial management organization does not implement its responsibilities, and the main researchers lack scientific spirit.