The General Administration of Market was established, Bi Jingquan served as Secretary, Zhang Maoren as Secretary!

According to a news report on March 22, the newly formed National Market Supervision Administration was formally established on March 21.

The former director of the State Food and Drug Administration and the party secretary, Bi Jingquan, served as Party Secretary of the State Administration of Market Supervision; Zhang Mao, former director of the State Administration for Industry and Commerce, served as director of the State Administration of Market Supervision; Jiao Hongren, former deputy director of the State Food and Drug Administration Director of the State Drug Administration; Li Li, former vice governor of Jiangxi Province, served as party secretary of the State Drug Administration.

Recently, the Central Committee of the Communist Party of China has issued the “Deepening Party and State Institutional Reform Plan.” The deepening of the State Council’s institutional reforms proposed that the State Administration for Industry and Commerce, the State Administration of Quality Supervision, Inspection and Quarantine, the State Food and Drug Administration, and the State Market Supervision Administration be established. General Administration.

According to the “Programme”, the State Administration of Market Supervision will include the State Administration for Industry and Commerce, the General Administration of Quality Supervision, Inspection and Quarantine, the State Food and Drug Administration, and the NDRC's price supervision, inspection, and anti-monopoly law enforcement duties. Anti-monopoly law enforcement, State Department anti-monopoly law enforcement duties.

The main duties of the State Market Supervision and Administration Bureau are: Responsible for comprehensive market supervision and management, unified registration of market entities and establishment of information publicity and sharing mechanisms, organization of comprehensive supervision of market supervision, implementation of anti-monopoly law enforcement, standardization and maintenance of market order, organization and implementation of quality Strong country strategy, responsible for quality and safety of industrial products, food safety, safety supervision of special equipment, unified management of measurement standards, inspection and inspection, certification and accreditation.

Taking into account the peculiarities of drug supervision, the State Drug Administration shall be established separately and administered by the State Administration of Market Supervision. The main responsibility is to take charge of drugs. cosmetic , registration and implementation of supervision and management of medical devices. drug The supervisory agency is only set up at the provincial level, and supervision of the behaviors of drug sales and sales is carried out by the city and county market supervision departments.

As the National Market Supervision and Administration Bureau, which is responsible for supervising and managing 100 million households in the market, the leadership structure has been officially released. We are full of expectations for future market supervision, especially drug supervision.

I remember that in the New Year’s address on December 31, 2017, then the then Director of the State Food and Drug Administration, Mr. Bi Jingquan, commented on the achievements of the food and drug supervision system in the past year: 'Solved many problems that have long been resolved but not solved.' It has become a major event that many people wanted to do in the past but did not do it.'

Bi Jingquan, 63, has been serving as the Deputy Secretary-General of the State Council since March 2008. He holds a bachelor's degree in economics, and has worked in various departments of the National Price Bureau and National Development and Reform Commission on price management and economic and trade work.

This non- medicine The director of professional background has indeed brought us many surprises and major changes in the work of drug administration since taking office in 2015.

The original State Food and Drug Administration, I am afraid, is one of the most vocally stressed government departments. The food and drug supervision has been on the road to reform, and various problems have also emerged one after another: The drug backlog has a serious backlog, and foreign listed drugs cannot be purchased at home. , The quality and efficacy of domestic drugs need to be urgently improved, and illegal activities in the field of pharmaceutical circulation are becoming increasingly prominent...

In spite of the difficulties, in the past two years, we have still seen a State Food and Drug Administration that is constantly making progress. With the leadership of Director Bi Jingquan, the State Food and Drug Administration has begun a transformation that will lead to new breakthroughs. Let CFDA have new vitality. , even activated the entire Chinese pharmaceutical industry.

This change was issued on August 9, 2015 by the State Council medical instruments "Opinions on reviewing and approving and approving the approval system" formally began. On October 8, 2017, the State Council's General Office issued the "Opinions on Deepening the Reform, Examination and Approval System Reform and Encouraging the Innovation of Drugs and Medical Devices" to rise.

On July 22, 2015, the State Administration of Food and Drug Administration decided to carry out drug clinical trial data verification on 1,622 applications for pending drug production that have been declared or imported, and officially launched a backlog of drug review cleanup work.

In August 2015, the State Council issued the "Opinions on the Reform of the Evaluation System for the Examination and Approval of Pharmaceuticals and Medical Devices". By June 2017, the number of pending drug registration applications had fallen from 22,000 in the peak of 2015 to 6,000. In the application for vaccine clinical trials, various applications for registration of Chinese medicines have been reviewed according to time limits. By the end of 2017, the number of drug registration applications awaiting review had been reduced to less than 4,000.

In February 2016, the State Council issued the Opinions on the Conformity Assessment of the Quality and Efficacy of Generic Drugs, which clearly defined the objectives and tasks of carrying out a consistent evaluation of the oral preparations of listed generic drugs in accordance with the standards consistent with the quality and efficacy of the original research drug. Incentives.

Up to now, there have been 24 batches of articles in two batches, the first to pass the consistency assessment.

In November 2015, the Standing Committee of the National People's Congress authorized the State Council to launch trials for the holders of drug marketing licenses in ten provinces and cities, which greatly mobilized the enthusiasm of scientific research institutions and researchers.

5. Further clarify the main responsibility of the holders of marketing licenses for drug research and development, manufacturing, distribution, use, and adverse reaction reports.

On May 5, 2016, the State Food and Drug Administration issued the "GPL (non-clinical research quality management specification)", which announced the implementation of the Non-clinical Research Quality Management Practice (GLP), Drug Clinical Trial Quality Management (GCP), and other regulations. , standardize drug development behavior.

Strict drug registration management, the establishment of a registration management system as the core, including more than 10 supporting documents and more than 120 technical guidelines for the registration management system.

Over the years, the national food and drug regulatory authorities have adopted a series of measures to raise the quality of pharmaceuticals by raising local standards to national standards and raising GMP certification standards.

Promote the reform of 'distribution service' and cancel Medicinal herbs Production Quality Management Specification (GAP) certification, delegating GMP certification duties to the provincial level. Strengthening on-site inspections and sampling inspections, strengthening post-event supervision.

In September 2017, the 11th Pharmacopoeia Commission was established. The main task of the committee was to deploy the 2020 version of the “Chinese Pharmacopoeia” preparation work, promote the reform of drug standards, strengthen the overall management of drug standards, and promote the further improvement of drug quality.

On May 3, 2016, the State Food and Drug Administration issued the Announcement on Remediation of Illegal Business Conduct in the Circulation of Drugs (No. 94 of 2016), implementing the requirements of the Party’s Central Committee and the State Council on the “four strictest” requirements for food and drug supervision. , Further rectify and standardize the order of drug circulation, severely crack down on illegal business operations, and carry out centralized rectification of illegal business operations in the field of drug circulation.

In June 2017, the CFDA formally joined the ICH (International Technical Registration Committee for Pharmaceuticals for Human Use). This is a milestone in the reform process of China's drug administration, which means that China's drug regulatory system has been truly integrated into the regulatory system approved by the international community.

The current 2010 version of GMP is basically in line with international standards. Some varieties have been approved and exported by developed countries and the World Health Organization. The quality of medicines in China will be greatly increased, drug review will also be accelerated, and people will be able to use imported drugs more quickly. Innovative medicine.

For 2018, Bi Jingquan once looked forward to this: The new year must have a new atmosphere, and it must have new works.

We also expect that under the leadership of the General Administration of Marketing, we can gradually move from a pharmaceutical country to a pharmaceutical country. Whether it be a drug supervisor or a medical person, we are full of hope.