Bi Jingquan: as a regulatory department, neither vacancy nor offside is allowed

Source: new Kangjie 2016-3-1 electronic supervision code: when an enterprise undertakes the main responsibility of building a product traceability system, bijingquan said bluntly to the recently controversial issue of electronic supervision code: "electronic supervision is an exploration in the process of supervision There are inevitably different understandings and even disputes about this exploration." First, the responsibility of food and drug regulatory departments is to maintain public health, to ensure the safety and effectiveness of drugs, and to use modern information technology to explore how to perform their duties, which is a manifestation of ideological emancipation and positive progress As a regulatory department, it is not allowed to be absent or overstepped The absence is dereliction of duty, dereliction of duty, omission, and overstepping is abuse of power Second, entrepreneurs want to pursue economic benefits, but they create wealth, increase employment and pay taxes for the society while pursuing economic benefits When possible, entrepreneurs are willing to make some contributions to the society Therefore, it is not easy to question the social responsibility of entrepreneurs Third, the enterprise is the main body of food and drug research and development and production, should assume the main responsibility of ensuring quality and safety, should assume the main responsibility of building product traceability system The formulation of any policy measures should fully consider its economy, effectiveness, fairness and legality, fully listen to the opinions of all sectors of the society, and obtain the understanding, cooperation and support of the regulatory objects Drug review: there is a large gap in reviewers To study the system, we need to retain Bi Jingquan's introduction The backlog of drug review has always been an arduous task for CFDA When the backlog of drug review reached the highest, it reached more than 32000 From the end of 2014, CFDA began to study and promote the reform of drug review and approval system In August last year, the State Council issued a reform document specifically, proposing to improve the standards of drug review and approval, promote the consistency evaluation of the quality and efficacy of generic drugs, implement the pilot of drug listing license holder system, simplify the procedures of drug review, accelerate the speed of drug review and improve the effectiveness of drug review Last year, the number of completed drug reviews by the drug review center increased by 90% compared with 2014, and now the number of drug backlog has dropped significantly New drugs have been approved three times in the past phase III clinical trials, now once, and the second and third clinical trials in the future will be communicated through meetings If they are approved, they will enter the next phase The application for clinical trials of generic drugs has been changed from the original approval system to the filing system, which greatly improves the efficiency of drug approval The key to improve the efficiency of drug approval lies in people The total number of reviewers in the drug review center of the United States is more than 5000 The actual number of reviewers in the drug review center of China is only 130 In addition, the backbone of the drug review center of China has lost a lot In recent three years, the number of reviewers in the first line has lost 1 / 3, and their salary to the enterprise is roughly 10 times that of the current drug review center Bi Jingquan said that the drug review center reviews the latest scientific research achievements of global high-tech enterprises, so we must be able to recruit first-class scientists, especially doctors with rich experience, to lead the review of new drugs on the market And our reviewers should also be commensurate with the large population, consumption and pharmaceutical countries, because we are not facing China's own enterprises, but global enterprises, as well as global high-tech enterprises Of course, if the review center is expanded to 5000 people like the FDA of the United States, Bi Jingquan can't imagine, even if 1000-2000 people can be given to the review center, it will be gradually expanded Therefore, it will take some time and hard work to fundamentally solve the problem of low efficiency of drug evaluation At present, CFDA is studying and formulating policies to recruit and retain reviewers At the same time, CFDA is studying and reforming the drug review system and the institutional scheme of drug review institutions The most important thing is to ensure the quality and safety of reviewed drugs through the reform of drug review system Self inspection and verification: if it is invalid, is there any need for the existence of drugs? On self inspection and verification, Bi Jingquan asked: the clinical trial data of drugs is an important basis for drug evaluation The premise of drugs is effectiveness, and the bottom line is safety In the past, we stressed more on safety and less on effectiveness If it is invalid, is there any need for drugs? On July 22, 2015, there were 1429 applications requiring self-examination and verification As of February 22, 2016, pharmaceutical enterprises had voluntarily withdrawn 1136 applications, accounting for 79% of the total number of self-examination and verification The total number of withdrawn and failed applications was 1184, accounting for 83% of the total number of self-examination and verification Bi Jingquan said that requiring the applicant to conduct self-examination on its clinical data and voluntarily withdraw the registration application with problems in authenticity and integrity is to remind the enterprise to pay attention to avoiding these legal risks, to develop drugs with reliable quality and accurate efficacy for family members, relatives and friends, and future generations, which is not only a legal issue but also a moral conscience issue and social responsibility issue " I would also like to remind the majority of food production enterprises, drug production enterprises, medical equipment production enterprises, health food production enterprises, as well as food and drug sales enterprises, legal representatives of catering enterprises, main managers, quality directors, to ensure that the production process and sales process strictly abide by the provisions of laws and regulations, strictly abide by the norms of quality control, and ensure that the data are recorded The record shall be true, complete and accurate, and any illegal act such as false record, adulteration and false propaganda shall be prohibited "