Yu Tao, director of the Shandong Provincial Food and Drug Administration, talks about services

In the eyes of many people, the Food and Drug Administration is a regulatory department, with supervision and inspection, law enforcement and case handling as the main business. This is a fact. But at the same time, we have also been committed to building a service-oriented institution, hoping that the work of the Drug Administration will create an optimal business environment for the development of Shandong's pharmaceutical industry.

First of all, strict regulation is also the best service

Some enterprises do not understand and resist supervision, and feel that the FOOD and Drug Administration has strict penalties and is not close to human feelings. But I think that strict management is the real love.

The industry knows that a bottle of medicine has two lives in a row, one is the life of the patient, and the other is the life of the enterprise. Once a product has a problem, it is the patient who is endangered first, but it is also fatal to the enterprise. Therefore, the Food and Drug Administration's strict management of enterprises is the same as the discipline inspection commission's strict management of cadres, and it is precisely for the better development of enterprises to prevent small problems from evolving into big problems and small mistakes from becoming big mistakes.

Some people may say that a bottle of medicine is not qualified, a cosmetic product does not have a Chinese label, which does not affect the use, is it necessary to punish? In fact, these unqualified penalties are clearly stipulated by laws and regulations. The reason for the strict penalties is to ensure 100% safety. We know the famous "Hayne's Law", behind every serious accident, there must be 29 minor accidents and 300 attempted precursors and 1000 accident hazards. Let go of the 999 small hidden dangers in front of you, and the big accident will definitely come out. Only when every small loophole is plugged and every hidden danger is eliminated, will there be no major problems.

A while ago, I read a book called The Truth About Generic Drugs, which had a very impressive sentence: "When I board a plane and find coffee stains on the small table board, I suspect that they have not maintained the engine." "As a drug regulatory department, it is necessary to always establish the concept of 100% drug safety, 99.9%, which will leave a hole for hidden risks." Only by "taking it" at any time and working towards the goal of 100% can we "get it". If our standard is reduced to 99%, then sooner or later there will be big problems and a serious blow to the development of the industry.

Second, the development of service enterprises is also the responsibility of the Food and Drug Administration

Regulators and companies are definitely not cat-and-mouse relationships. Our attitude towards enterprises is like parents treating their children, caring but never doting, making mistakes must be criticized for education, but scolding and punishing is not the fundamental purpose, the purpose is to give him a clear reason, in order to grow up better and healthier. Therefore, for enterprises, they must not be allowed to grow freely and barbarically, but if something goes wrong, they cannot be punished or closed. We only hope to help enterprises plug risk loopholes, improve management systems, improve product quality, and build century-old stores.

We have implemented a mechanism of "equal emphasis on punishment and help". Just like Chinese medicine not only treats the existing disease but also cures the disease, the main responsibility list and the negative list are introduced, telling the enterprise "what should be done and what cannot be done". In the inspection, the first meeting will be held into a policy and regulation publicity meeting, the inspection process will be made into a training meeting, and the last meeting will be used as an education interview meeting, detailed feedback on the hidden risks found, supervision and correction immediately, and prevention of problems before they occur. For problems that are prone to occur in similar enterprises, timely release warnings, issue "understanding papers", give preventive injections in advance, change them if they have them, and encourage them if they do not. Serious illegal enterprises that subjectively and deliberately, maliciously falsify, and have no bottom line will be resolutely severely punished, punished to the point of people, and the industry is prohibited from entering. For enterprises that make mistakes without subjective intent, while strictly investigating, the supervision office and experts are selected to help each other, take the initiative to provide door-to-door service, consult and prescribe medicines for the quality management system and production and operation development of enterprises, and supervise the improvement of standards. Smooth communication channels, formulate norms such as post-market risk management guidelines for drugs, guide enterprises to "what to do and how to do it", and urge enterprises to abide by the bottom line of drug quality and safety, and do not touch the legal red line.

Third, benefiting the masses is the meeting point between regulatory authorities and enterprises

The reason why we want to serve enterprises and support the development of the pharmaceutical industry is, in the final analysis, to support pharmaceutical companies to make good drugs for the masses, drugs that work, and drugs that can relieve pain, and to support pharmaceutical companies to better serve the people, rather than simply supporting pharmaceutical companies to generate income. While it is important that the development of the pharmaceutical industry brings tax revenue and GDP, it cannot be used as the sole and ultimate goal.

We must adhere to the people-centered development thinking, take the road of high-quality development, and resolutely do not carry bloody GDP. The ultimate goal of development is to enable people to live happier and more secure lives, not for the sake of development.

For the good drugs and new drugs that the masses urgently need and are waiting to save their lives, if they are listed one day earlier, the masses can benefit one day earlier and suffer less than one day. For example, lupus erythematosus was almost a terminal illness in the past, and there was no specific medicine to cure. The "global new" new drug tetacil for injection developed by Rongchang Pharmaceutical can just overcome this stubborn disease and give patients the hope of rebirth. Some generic drugs are available in the morning for one day, which can greatly reduce the economic burden on patients. For example, gefitinib, which treats non-small cell lung cancer, was previously imported at 5,000 yuan per bottle, and after the domestic drug of Qilu Pharmaceutical was listed, the medical insurance purchase price of this drug was reduced to more than 500 yuan; after the completion of the clinical phase I trial of bevacizumab alone, it prompted the imported drug to reduce the price by 63% in the national medical insurance negotiations. For such drugs that the masses urgently need, we must break the routine, guide the whole process, and rely on the upper support to promote their research and development as soon as possible.

In terms of service enterprises, as long as it is a good measure taken by other provinces, we will learn from it and find ways to do better; for those provinces that do not have strong expectations and eager needs of enterprises, as long as they do not violate laws and regulations, we will actively explore, boldly try, and try to meet the needs of enterprises as much as possible. For example, the COVID-19 vaccine independently developed by Parnabis is one of the most potential vaccines to block the Delta virus. In order to accelerate the listing to defeat the epidemic, we have implemented the "three zero model" of zero distance, zero rework and zero waiting, and actively serve research and development, which can be said that where the enterprise research and development, the service and supervision will follow up.

In short, our basic attitude and principle is that pharmaceutical companies are responsible for the people, and we will clearly support and help; if we are not responsible for the people, we will unceremoniously punish and sanction.

Text/Yu Tao, Secretary of the Party Group and Director of the Shandong Provincial Food and Drug Administration

New Media Editor: Li Yizhen

Overall planning: He Xuan

【Source: China Medical News】