New Year's Speech, Reform and Opening-up and Strive for a New Journey of Drug Administration


Release time:

2019-01-03

We bid farewell to the challenging and promising 2018 with the brilliant achievements of 40 years of reform and opening up, and usher in a promising and hopeful 2019 with the lofty ambition of starting again with reform and opening up.

At this moment of leaving the old and welcoming the new, we extend New Year's greetings to the cadres, employees and relatives of the national drug regulatory system! I would like to express my heartfelt thanks to friends from all walks of life who care about and support drug supervision!

In 2018, under the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, we conscientiously implemented the spirit of the 19th National Congress of the Communist Party of China and the Second and Third Plenary Sessions of the 19th Central Committee, strengthened the "four consciousnesses", strengthened the "four confidences", and resolutely implemented the "Two Maintenance", earnestly implemented the decisions and deployments of the Party Central Committee and the State Council, solidly promoted institutional reforms, properly handled problematic vaccine cases, carried out inspections and rectification, comprehensively investigated risks, it has withstood the pressure, withstood the test and achieved results that were not easy to achieve.

Over the past year, we have resolutely implemented the central government's decision-making and deployment on institutional reform, scientifically planned the "three decisions" regulations, achieved maximum optimization in functions, institutions, and establishment, and successfully completed the establishment of the State Food and Drug Administration, laying a good foundation for the next step of supervision.

Over the past year, we have fully cooperated with the investigation team of the State Council to investigate and deal with the Changchun Changsheng vaccine case, together with relevant departments to verify the substandard vaccine of Wuhan biological titer, and actively and steadily carry out follow-up disposal work. At the same time, learn lessons, draw inferences from one instance, and improve the vaccine management system.

Over the past year, we have conducted a systematic investigation of hidden drug safety risks across the country, conducted a thorough investigation of vaccine manufacturers for all varieties, processes, and chains, and implemented full coverage supervision and inspection of high-risk products such as blood products., Cosmetic manufacturers carry out targeted inspections, establish risk point accounts one by one, study targeted resolution measures, and strive to eliminate risks in the bud.

Over the past year, we have continued to deepen the reform of the review and approval system for drugs and medical devices, and further promoted the evaluation of the quality and efficacy of generic drugs. A number of clinically urgently needed and independent innovative drugs such as the nine-valent human papillomavirus vaccine have been successfully launched, and 48 innovative drugs have been approved for the market throughout the year. Import non-special purpose cosmetics administrative examination and approval to record.

Over the past year, we have actively promoted the revision of laws and regulations. The "Vaccine Administration Law (Draft)" has been submitted to the Standing Committee of the National People's Congress for deliberation, the revision of the "Drug Administration Law" has been accelerated, and the legislation of the drug patent term compensation system has been advanced in an orderly manner. Positive progress has been made in the construction of professional drug inspectors and the construction of intelligent supervision. He was successfully elected as a member of the Management Committee of the International Technical Coordination Committee for Registration of Medicines for Human Use, and served as the rotating chairman of the International Medical Device Regulatory Agency Forum for the first time.

Over the past year, we have persisted in comprehensively strengthening party building, conscientiously fulfilling the responsibility of administering the party strictly in an all-round way, strengthening the building of grass-roots party organizations, strictly implementing the spirit of the eight regulations of the CPC Central Committee, and seriously investigating and dealing with violations of rules and discipline. All efforts have been made to carry out the central inspection and rectification, and the standards have been refined. All rectification tasks are being carried out in an orderly manner according to the time node.

2019 is the 70th anniversary of the founding of New China, the key year for building a moderately prosperous society in an all-round way, and the start of the new drug supervision system after the institutional reform. Under the guidance of Xi Jinping's thought of socialism with Chinese characteristics in the new era, we should thoroughly implement the spirit of the 19th CPC National Congress and the second and third Plenary sessions of the 19th CPC Central Committee, conscientiously implement the "four strictest" requirements in accordance with the arrangements of the Central Economic work Conference, adhere to the general tone of seeking progress in the midst of stability, adhere to the new concept of development, focus on strengthening the management of the whole life cycle of drugs, and promote the scientific development of supervision, we should pay attention to reform, ensure safety, improve quality and strengthen the foundation, constantly improve the regulatory system and mechanism, innovate the supervision methods and methods, strengthen risk management, deepen the implementation of responsibilities, improve the scientific, legal, international and modern level of drug supervision, earnestly safeguard the health of the people, and make new contributions to the sustained and healthy development of the economy and society.

Reform and opening up again, forge ahead in the new journey of drug supervision. The cadres and workers of the national drug administration system should cherish the trust of the organization, bear in mind the entrustment of the people, and be trustworthy and reliable drug administration cadres of the party and the people. We should be diligent in learning, have the courage to practice, be good at research, and constantly temper the broad shoulders and hard strength of the officers and entrepreneurs. We should have the courage to reform, forge ahead, and constantly promote innovation in thinking, mechanism and methods. It is necessary to be dedicated to the public, unite and cooperate, seek truth and be pragmatic, and create a loyal, harmonious, innovative, efficient, and clean drug supervision culture.

Comrades! Let us unite closely around the Party Central Committee with Comrade Xi Jinping at the core, emancipate our minds, forge ahead, overcome difficulties, work hard, and strive to write a new chapter in the cause of drug supervision with a new atmosphere and new actions!