Apricot forest spring warm, orange well spring fragrance Bijing spring low-key comeback.

Two years ago, Bi Jingquan, the former party secretary and deputy director of the State Administration of Market Supervision and Administration, suddenly "resigned" with the determination of the strongman to "promote medical innovation and thorough reform", disappearing from the public's view.
two years of silence, Bi Jingquan is still a drug supervisor, diligent and conscientious, reading history and economic books, with little contact with the outside world.
During this period, from time to time there was speculation about the whereing of Bi Jingquan's path news, including transfer to the South-North Water Transfer Office, in charge of a well-known university management college, but ultimately proved to be caught in the wind.
now, he's back in the low profile.
: On August 27, 2020, the 13th meeting of the Standing Committee of the 13th National Committee of the CHINESE People's Political Consultative Conference (CPPCC) concluded in Beijing.
the meeting, five members of the CPPCC National Committee were added, namely Bi Jingquan, Miao Wei, Hu Zejun, Liang Wei and Yu Shugang.
, the addition of Bi Jingquan, Miao Wei as deputy director of the Economic Commission.
data show that the five new CPPCC members have previously held important positions in various ministries and other units, such as Miao Wei previously served as the Secretary of the Party Group of the Ministry of Industry and Information Technology, Hu Zejun previously served as Auditor-General of the Audit Office, Liang Wei was previously the Director of the Personnel Bureau of the CPPCC General Office, and Yu Shugang was previously the Minister of Culture and Tourism.
65-year-old Bi Jingquan is one of the most high-profile people in the short period of personnel news.
He worked for the National Development and Reform Commission for many years, and was later raised from Deputy Secretary-General of the State Council and member of the Party Group of the Organs to Director-General of the State Food and Drug Administration, Secretary of the Party Group, and then Secretary and Deputy Director-General of the Party Group of the State Administration of Market Supervision and Administration after the institutional reform in 2018.
's a new job! News spread quickly inside and outside the pharmaceutical industry, many people forwarded a circle of friends to send blessings, hope that the pharmaceutical industry has led the biggest changes in a decade officials to achieve new results.
the current staff of the drug regulatory system have maintained a consistent caution, only to talk about the news on a small scale.
but soon, people realized that Bi Jingquan "is no longer a person in the medical profession", but returned to the economic world where he had played half his life.
Few officials to the ministerial level, only more than three years, has won the system and outside the unanimous praise, and after a sudden dismissal is still constantly mentioned, regret, and even evaluation of "everyone loves Bijingquan."
also in August, Bi Jingquan led the opening, the State Council issued a document to implement the drug medical device review and approval system reform for a full five years.
ministerial cadre, who has rewritten the history of China's drug regulation, has attracted much attention and interpretation for almost every change in his position.
the praise, light and sudden fall behind him have to do with the biggest changes in China's drug regulatory system over the past five years.
the iron-fisted reform won praise, Peking University economics graduate, "political reformist" official Bi Jingquan led the resignation, it is his career in the highest reputation and public praise of the moment.
his reform ideas clear, study professional issues, strong executive power, willing to listen to corporate opinions, the media is also quite well-intentioned.
, he was called "Mr. Bi" by the pharmaceutical industry, reflecting not only enough majesty but also the recognition and love of the industry.
January 2015, Bi Jingquan served as Deputy Secretary-General of the State Council for seven years before taking the helm of the former State Administration of Food and Drug Administration.
, he worked in the NDRC system for 26 years as deputy director of the NDRC.
economy is the best and most familiar area of Bijingquan.
1984, Bi Jingquan joined the State Price Bureau, which was included in the National Development and Reform Commission's predecessor, the National Planning Commission, in 1994.
year, the rich and powerful Bijingquan an important task is: drug prices.
he has repeatedly interviewed the media on drug prices, but also made it clear that he supports drug price transparency and improve the health care reimbursement policy.
china's drug prices have been controlled by the National Development and Reform Commission since 2000, and the government hopes to drive down overall drug prices by limiting prices.
, the price authorities shall exercise government-directed price (maximum retail limit) for medicines in the medical insurance catalogue and special drugs outside the catalogue.
At this stage, the NDRC adopted the way of setting the highest retail price below the market price, and carried out many price reduction actions in more than ten years to curb the unreasonable rise in some drug prices, leaving many problems and hidden dangers.
After 2010, the National Development and Reform Commission began to carry out drug price reform, the then Deputy Secretary-General of the State Council Bi Jingquan strongly supported, the main reason is that the price-limiting measures at that time, one can not timely reflect and guide market supply and demand;
, it is imperative and ripe to speed up drug price reform, eliminate the management of the maximum retail price of drugs, and establish a new mechanism for drug price formation.
January 2015, Bi Jingquan left his post as Deputy Secretary-General of the State Council and bet the new Director General of the State Food and Drug Administration.
, who is not familiar with the pharmaceutical industry, spent nearly six months researching and understanding the industry.
In April and May 2015, two officials in key positions of the General Administration of Food and Drug Administration were involved in an accident: Zhai Hongzhang, then deputy director of the Drug Review Center, was taken away for investigation at a meeting of the director of the Drug Review Center, and Tong Min, then director of the Medical Device Supervision Department, was taken away on suspicion of serious disciplinary violations, sounding the alarm to the entire system.
Only a few months later, on May 5, 2015, with the consent of the State Council, the National Development and Reform Commission, together with the State Health and Planning Commission and the Ministry of Human Resources and Social Security, jointly issued a Notice on the Issue of Opinions on Promoting Drug Price Reform, and decided to cancel the government pricing of most drugs from June 1, 2015, improve the drug procurement mechanism and play the role of health care fee control.
drug prices are mainly formed by market competition, China's drug price management into the market era.
three months later, on August 18, 2015, Bi Jingquan took office and pushed for the reform of the drug review and approval system, which was officially released in the form of a State Council document, "The State Council's Opinions on Reforming the Drug Medical Device Review and Approval System" (Guofa (2015) No. 44).
the 4,000-word document ("No. 44"), the biggest change in China's drug approval in a decade under Mr. Bi's leadership has surfaced.
Looking at the media reports before the reform, China's drug regulation and market is almost "to the dark moment", chaos: "India's first person to buy anti-cancer drugs" rolled into the judicial vortex; The underlying reasons are related to the stagnation of drug approvals and industrial development chaos in China over the past decade.
during his term in office, Bi Jingquan high-profile drug supervision, new drug registration review and new drug clinical trials in the problem of "knife", referring to drug supervision has been "heavy licensing, light process" of the persistent disease.
only clinical trials to verify this one, the General Administration of Primary Medicine issued 26 announcements at that time, resulting in 1622 clinical trial registration applications about 80% of the project voluntarily withdrawn, 30 were rejected.
11 institutions have been investigated and the suspected crimes handed over to the public security organs for handling.
In order to improve the quality of generic drugs, he promoted the implementation of consistent evaluation and the "orange book system", to ensure the quality of the review, he vigorously promoted the transparency and scientific review and approval of drugs, and for the first time from the Fda to bring a number of experts to the China Pharmaceutical Review Center as "chief reviewer", to encourage innovation, he led the FDA to change the definition of old new drugs, open the market licensing system and a series of priority review policies to open the door to a truly good drug market.
" is very bold, dare to assume.
" this is the industry outside the consensus assessment of Bijingquan.
the eyes of the subordinates, this official at the ministerial level has no official shelf, but also very good at learning, encountering professional problems, not only will not hide the lack of knowledge, but also find ways to find professionals to understand.
There are also many people said that Bi Jingquan is very "strong", "too strong medicine" let the industry breathable enough, only the drug reform policy "see you on Friday" this article can be seen - every time before the introduction of major policies, Bi Jingquan each document will personally look at, the Department of the Drug Administration will also be linked to the axis of overtime, in order to rush to the end of the week before the end of the work day released.
photo source: Screenshots of the Drug Audit Center's promotional tablets, despite the storm of reform and the heavy workload, have been recognized throughout the drug regulatory system as the best time in decades.
" inspired a never-before-seen sense of job value, tired also has a head.
," commented a senior reviewer at the National Drug Review Centre.
" Secretary Bi to do practical things, but also very open-hearted, willing to listen to us.
" In 2016, the executives of a domestic innovative pharmaceutical company as industry representatives and the Drug Administration face-to-face exchanges, three hours of meetings, Bijingquan open-door, no official words, listen carefully to the views and suggestions of enterprises, so that he felt that the leader "very unusual."
Industry unanimous evaluation: During bi's three years in office, the former State Food and Drug Administration (CFDA) solved a series of persistent problems of China's pharmaceutical system, such as the backlog of reviews that have not been resolved in the past 20 years, such as inadequate quality of generic drugs and slow introduction of new drugs, which greatly narrowed the gap between the urgent needs of patients for drug use and the poor drug regulatory system, and introduced policies and implementation programs that are in sync with or in line with international standards.
all of this has allowed him to gain a rather positive political voice.
results soon became apparent.
a large multinational company submitted an application for a new drug in early 2017, which is suitable for serious cancer and is eligible for priority review, was approved in March 2017 and entered the market a month later.
chinese medicines have also benefited from priority review channels.
2017, the locally developed Ebola vaccine was approved for new drug applications in just ten days, but only on the condition that the third phase of the trial be completed at a later stage.
2018, the 9-price HPV vaccine was officially approved in just eight days from April 20 to April 28.
Photo Source: Screenshots of the Drug Audit Center's propaganda film in the field of medicine and medicine, the famous reform is not uncommon, but many are stranded because of "up and down not change", and some because the reform is too strong resistance to stall, more will be because people go to the political situation and the flag.
drug reform led by Mr. Bi Jingquan also faced questions at first.
time and data speak.
On August 18, 2020, exactly five years after the State Council issued the Opinions on Reforming the Drug Medical Device Review and Approval System, the China Pharmaceutical Daily, an industry newspaper directly under the State Drug Administration, published an article, "The Five-Year Report Card of Drug Review Reform", which proved the continuing results of the reform by numbers.
backlog of new drugs has been significantly reversed: by the end of 2019, the number of registration applications waiting in line for review had fallen from nearly 22,000 at its Peak in September 2015 to 4,423;
in terms of the speed of approval of imported drugs, the first time since 2018 that imported drugs have been approved in China is 6.25 years later than the international (US, EU, Japan) approval time, and the average lag time in 2019 is 5.55 years.
14 of the new drugs approved internationally after 2017 have been approved in China in 2019.
The 2019 Drug Review Report issued by the State Drug Administration in July 2020 shows that the Drug Review Center has reviewed and adopted 164 applications for the listing of new drugs, including 10 category 1 innovative drugs, 58 imported original drugs (including new adaptation certificates);
53 of the new drugs approved for sale in 2019 are innovative drugs approved for the first time, according to the January 2020 statistics.
) - The U.S. Food and Drug Administration (FDA) approved 48 new drugs for sale in 2019, surpassing the U.S. in the number of innovative drugs approved in China.
just five years ago, there were only a handful of innovative drugs approved for listing in China.
2011-2015, only four of the 42 innovative anti-tumor drugs were approved for sale in China.
Some people have summarized the five characteristics of the regulatory thinking of the Drug Administration in the new period under Bi Jingquan's control: clarifying the identity of the enterprise as the subject of responsibility, the regulator gradually retreating to the role of rule-setr;
" all of this is a signal to return to the essence of drug regulation - to ensure that drugs are safe, effective and of controlled quality.
is a solid reform, not a movement, but a systematic, step-by-step reform.
Yue, a professor at Shenyang Pharmaceutical University's School of Business Administration, has previously commented that she has been concerned about drug regulatory reform and participated in the revision of the Drug Administration Law.
two years of silence, it is customary for provincial and ministerial officials to "retire" when they turn 65, but in 2018, the 63-year-old Bi Jingquan took office in changchun Changsheng vaccine incident that caused a national sensation.
is well known for what has happened since then.
July 15, 2018, the former State Administration of Quality Supervision and Administration found in the flight inspection that Changchun Changsheng company's rabies vaccine production records were false, ordered it to stop production, and withdraw the GMP certificate.
responsible persons were arrested by the judiciary, causing national concern and strong public opinion.
August 16, the Standing Committee of the Political Bureau of the Communist Party of China (CPC) Central Committee held a meeting to hear a report on the investigation and accountability of vaccine cases involving Changchun Changsheng Company in Jilin Province.
meeting announced that Jin Yuhui, vice governor of Jilin Province, was removed from office, And Li Jinshua, vice governor of Jilin Province, ordered his resignation, asking Changchun Mayor Liu Changlong, the former head of the General Administration of Food and Drug Administration Bi.