The 14th Five-year Plan for National Drug Safety and Promotion of High Quality Development

This Plan is formulated in accordance with the 14th Five-Year Plan for National Economic and Social Development of the People's Republic of China and the Outline of the Vision Goal 2035 for the purpose of ensuring drug safety, promoting high-quality development of drugs, modernizing the drug regulatory system and regulatory capacity, and protecting and promoting public health.

I. Current situation and situation

(1) Achievements made

During the 13th Five-Year Plan period, China's drug safety supervision system and mechanism have been gradually improved, the quality and variety of drugs have been steadily improved, innovation capacity and service level have been continuously enhanced, and the development goals and tasks of the 13th Five-Year Plan for National Drug Safety have been successfully accomplished.

Public demand for medicines is better met. There are 18,000 varieties of medicines and 155,000 approval numbers. 124,000 first-class filing certificates for medical devices, 121,000 second-class and third-class registration certificates; Basically meet the needs of clinical use. Monitoring and early warning of drugs in shortage have been strengthened, and drug reserves in regular shortage have been established at the central and local levels. Domestic vaccines account for more than 95 percent of the country's actual vaccination, and we can rely on our own capabilities to cover all planned vaccines.

Full-life cycle supervision has been strengthened. We will establish and improve the system of drug marketing authorization holders and medical device registrants, and urge enterprises to strictly fulfill their drug safety responsibilities in all links. We will reform and improve the vaccine management system and strengthen full-process and life-cycle supervision. We will strengthen standardized management of clinical trials and establish a platform for clinical trial institutions to record and manage clinical trials. We have comprehensively strengthened on-site inspections and supervised sampling inspections, and carried out special campaigns to improve the quality of Traditional Chinese medicines prepared in ready-to-use pieces. We have launched special campaigns to clean the Internet for medical equipment and cosmetics. Improve the reporting mechanism for adverse drug reactions and medical device adverse events.

Reform of the review and approval system continued to deepen. We will establish and improve the procedures for expediting drug listing and registration, and constantly improve systems for indication team review, project manager, technical dispute resolution, and disclosure of review information. We reviewed and approved 674 new drug applications, including 51 innovative drugs. 39 applications for the marketing of clinically urgent drugs were approved. We made solid progress in the consistency evaluation of the quality and efficacy of generic drugs, published 3,963 product regulations in the reference preparation list, and passed the consistency evaluation on 964 applications for 278 varieties. The special review procedure for innovative medical devices was implemented, and 109 innovative medical devices and 35 urgently needed clinical medical devices were approved to enter the market. The import of ordinary cosmetics was adjusted from approval management to record management, new cosmetics raw materials were changed from unified registration management to registration management only for new raw materials with higher risks, special cosmetics administrative license continued to implement the commitment system of approval, the time limit for review and approval was reduced from 115 working days to 15 working days.

Laws, regulations and standards systems have been constantly improved. We will further improve the legal system for drug management covering the whole process of research, production, marketing and use. We comprehensively revised the Drug Administration Law, introduced the world's first vaccine administration law, revised the Regulations on the Supervision and Administration of Medical Devices, and formulated and promulgated the Regulations on the Supervision and Administration of Cosmetics. The 2020 edition of the Pharmacopoeia of the People's Republic of China will be released, and the Measures for the Administration of Medical Device Standards will be issued. We issued 125 guiding principles for drug technology and 399 guiding principles for medical device registration. 710 medical device standards have been issued, and the current effective medical device standards are more than 90% consistent with international standards. The Catalogue of Used Cosmetic raw materials was published, which included 8,972 items of used cosmetic raw materials, and the Catalogue of Prohibited Cosmetic Raw Materials was updated, which included 1,393 prohibited raw materials.

The drug regulatory capacity has been improved across the board. We strengthened the training of professionals, and accelerated the establishment of a team of high-quality drug inspectors with both professional and part-time roles. China implemented the Scientific Action Plan for Drug Regulation, and designated 45 sFDA key laboratories in the first batch. Built vaccine information tracing system, the drug safety "cloud" is launched operation, the implementation of electronic medical device registration declaration, pilot enabled the electronic registration certificate of medical equipment, medical equipment production regulation trading platform and network monitoring system be put into use, cosmetics to register for the record to realize online, all the regulatory information level to further improve. The level of drug regulation internationalization has been significantly improved, and the company has been successfully elected as a member of the management Committee of the International Pharmaceutical Registration Technical Coordination Committee for Human Use, successfully held two management committee meetings as the chair of the International Medical Device Regulatory Bodies Forum, and fully participated in the work of the International Cosmetics Regulatory Alliance.

Remarkable progress has been made in providing services for epidemic prevention and control. Since the outbreak of COVID-19, a working mechanism for joint research and examination has been set up in an unusual way, and the emergency approval and quality supervision of Novel coronavirus test reagents, medical protective suits, medical masks and therapeutic drugs have been made in an effort to achieve phased strategic results in China's epidemic prevention and control. The novel Coronavirus vaccine has been approved for marketing with conditions in strict accordance with laws and regulations and internationally recognized technical standards, and we have actively supported vaccine manufacturers in increasing production, continuously improving the quality and efficiency of vaccine batch issuance, providing strong support for mass vaccination of novel Coronavirus vaccines.

(2) Problems and situations

While affirming the achievements, we must clearly realize that the development of China's pharmaceutical industry is not balanced and insufficient, the safety, effectiveness and accessibility of drugs still need to be further improved, and the whole life cycle supervision work still needs to be improved. New technologies, new methods and new business models of modern biomedicine are changing with each passing day, posing challenges to traditional regulatory models and capabilities. The level of drug regulatory information needs to be further improved, and the construction of technical support system needs to be strengthened. The problems of the mismatch between the strength of the drug regulatory team and the regulatory task and the weak professional ability of the regulatory personnel are still prominent. The COVID-19 outbreak reflects the growing risks of emerging diseases facing humanity, creating new demands for drug development, safety and efficacy.

At present, the CPC Central Committee and The State Council have put forward new and higher requirements for drug safety, and made a series of major plans on accelerating the introduction of urgently needed drugs into the market, reforming and improving the vaccine management system, and inheriting, innovating and developing TRADITIONAL Chinese medicine. The public has higher expectations for the quality and safety of medicines, and the demand for the variety, quantity and quality of medicines has kept rising rapidly. The pharmaceutical industry has a strong demand for a fair, orderly and predictable regulatory environment, and it is urgent for the regulatory authorities to further improve and optimize the review and approval mechanism, improve the service level and regulatory efficiency, further improve the transparency of the review process, and support the pharmaceutical industry to achieve high-quality development through strong supervision.

Ii. General principles and development goals

(1) Guiding ideology

Holding the great banner of socialism with Chinese characteristics, thoroughly implement the party's nineteenth spirit and the 19th session of the previous session, adhere to marxism-leninism, MAO zedong thought, deng xiaoping theory and "three represents" important thought, the concept of scientific development, xi jinping, the new era of socialism with Chinese characteristics as a guide, fully implement the party's basic theory, basic line, basic strategy, Push forward "five one" the overall layout, coordination advances the strategy of "four comprehensive" layout, earnestly implement the jinping general secretary "four most strict" requirements, based on the new stage of development, carry out the new development concept and build a new development pattern, insist on people first, supremacy of life, always adhere to seek improvement in stability work tone, adhere to the scientific, under the rule of law, internationalization and modernization direction, We will continue to deepen regulatory reform, strengthen inspection and law enforcement, innovate regulatory methods, and improve regulatory capacity. We will accelerate China's transformation from a major pharmaceutical country to one that is strong in the pharmaceutical industry, and better meet the health needs of the people.

2. General Principles

Upholding the overall leadership of the Party. The Party's leadership runs through the whole process and every link of drug regulatory work, and the party and the government should take the same responsibility to protect the soil and fulfill their responsibilities, so as to provide a fundamental guarantee for ensuring drug safety and realizing high-quality development.

We will continue to reform and innovate. We will innovate the concept of drug regulation, deepen reform of regulatory systems and mechanisms, develop regulatory science and technology through multiple channels, give full play to the role of regulation in guiding and promoting the vitality and creativity of the pharmaceutical industry, and promote the transformation and upgrading of the pharmaceutical industry.

We will adhere to scientific oversight. Correctly grasp the relationship between ensuring drug safety and promoting industrial development, create a regulatory environment conducive to high-quality development, highlight the full life cycle supervision of drugs with strict prevention at the source, strict control in the process and strict risk control, and firmly guard the bottom line of drug safety.

We will uphold law-based oversight. We will establish and improve a rigorous and complete legal system and standard system for drug supervision, strengthen supervision over law enforcement, strictly regulate law enforcement, severely investigate and punish illegal and criminal acts, and create a fair and just legal environment.

Adhere to social governance. We will strictly implement the main responsibility of drug safety enterprises, the regulatory responsibility of departments and the management responsibility of local governments, encourage industry associations and the public to participate in drug safety governance, and promote the formation of a drug safety governance pattern featuring government supervision, business owners' responsibility, industry self-discipline and social collaboration.

3. Long-term goals for 2035

By 2035, China's scientific, efficient and authoritative drug regulatory system will be further improved, and its drug regulatory capacity will reach the advanced international level. Drug safety risk management capacity has been significantly improved, and laws, standards, and systems covering the whole life cycle of drugs have been put in place. The efficiency of drug review and approval was further improved, and the technical support capacity for drug supervision reached advanced international levels. The safety, effectiveness and accessibility of medicines have significantly improved, effectively promoting the prevention of major infectious diseases and the treatment of intractable and rare diseases. Significant progress has been made in the high-quality development of the pharmaceutical industry, and the level of the industry has been significantly improved. The pharmaceutical innovation and research capacity has reached an internationally advanced level, excellent leading industrial clusters have been basically formed, and the inheritance and innovation development of TCM has entered a new stage, basically transforming the pharmaceutical industry from a big country to a strong one.

(4) Main development goals for the 14th Five-Year Plan Period

By the end of the 14th Five-Year Plan period, the overall drug supervision capacity was close to the international advanced level, the level of drug safety guarantee continued to improve, and the people became more satisfied with and assured of the quality and safety of drugs.

The regulatory environment supporting high-quality industrial development will be improved. We continued to deepen reform of the review and approval system, approved a number of innovative drugs urgently needed for clinical use, and sped up the marketing of innovative drugs of clinical value to promote public health. The ability to evaluate innovative products has been significantly improved, and global innovative drugs and innovative medical devices applied in China will be listed in China as soon as possible. Formulated and revised 2,650 standards for drugs, medical devices and cosmetics, and added 480 guiding principles.

Vaccine supervision reached the advanced international level. Passed the evaluation of who national regulatory systems for vaccines. We will actively promote the ability of provincial drug inspection institutions of vaccine manufacturers to sign and issue batches of major vaccine varieties within their jurisdiction.

New progress has been made in the inheritance, innovation and development of TCM. A preliminary evidence system combining TCM theory, human experience and clinical trials has been established. Gradually explore and establish safety evaluation methods and standard systems in line with the characteristics of Traditional Chinese medicine. The modern supervision system of TCM has been improved.

Considerable progress was made in building a contingent of professionals. Cultivate a group of high-level international advanced level reviewers, inspectors and professional quality in the field of inspection and testing discipline leaders. The professional quality of the drug regulatory team has been significantly improved, and positive results have been achieved in the professional construction of the team.

The technical support capacity has been significantly enhanced. A full-life cycle pharmacovigilance system has been initially established. Positive results have been achieved in China's Scientific action Plan on Drug Regulation, and a number of new regulatory tools, standards and methods have been introduced. The capacity of drug inspection and testing institutions has been significantly improved.

Main tasks

(1) Implementing whole-process supervision over drug safety

1. Strict supervision of development. Strictly supervise the implementation of the quality management specifications for drug non-clinical research, drug clinical trial and medical device clinical trial, with emphasis on strengthening clinical trial verification to ensure the authenticity and reliability of data. We will improve the drug registration and management system.

2. Strict supervision of production links. We will strictly supervise the implementation of the quality management standards for the production of drugs, medical devices and cosmetics, carry out inspections and patrols of key manufacturers of vaccines and blood products, and continue overseas inspections. We will continue to formulate and implement a problem-oriented sampling inspection plan, with the focus on strengthening the inspection and sampling of selected products purchased centrally organized by the state, products evaluated through the consistency of the quality and efficacy of generic drugs, sterile and implanted medical devices, and children's cosmetics.

3. Strict supervision of operation and use. Local drug regulatory departments at all levels shall further strengthen supervision and inspection according to their duties, urge drug trading enterprises to strictly implement drug trading quality management standards and medical device trading quality management standards, urge drug users to continue legal compliance, and steadily improve the standardization level of drug trading and use. To study the dispensing and use management system of preparations from medical institutions urgently needed in medical associations, and reasonably promote their shared use in medical associations. Strengthen drug wholesale, retail chain headquarters regulation of third-party platform, online sales, increase the use of drug retail and units, such as the medical equipment management enterprise supervision and law enforcement, sustained risk hidden perils, urge the timely report adverse drug reactions and adverse events of medical equipment, and further enhance the level of basic drugs and medical devices quality assurance.

4. Strict supervision of online sales. We will improve the regulatory system for online sales, and study new regulatory mechanisms that adapt to new technologies, new forms of business, and new business models. We will strengthen supervision and management of online sales of drugs, medical devices and cosmetics, improve the monitoring platform for violations of laws and regulations in online trading of drugs and medical devices, timely investigate and dispose of risks arising from online sales of drugs, medical devices and cosmetics, and improve the pertinence and effectiveness of supervision.

5. Strict supervision and law enforcement. Strengthen the law enforcement duties of national and local drug regulatory departments at all levels, rely on the existing institutional resources to strengthen the inspection and law enforcement forces, straighten out the working relationship, improve the inspection and case handling mechanism, strengthen the coordination of inspection and inspection and law enforcement linkage, and improve the effectiveness of supervision and law enforcement. The handling of cases will be taken as an important indicator for the assessment of local drug regulatory departments at all levels, and the inspection and law enforcement efforts will be strengthened to seriously investigate and punish illegal behaviors. We will deepen coordination between administrative law enforcement and criminal justice, and crack down on all kinds of illegal and criminal acts. We will strengthen oversight and law enforcement information disclosure.

2. Supporting industrial upgrading and development

1. 3. Artificial Pancreas We will continue to carry out the national drug Standards Improvement action plan. To compile the 2025 edition of the Pharmacopoeia of the People's Republic of China. Strengthen international coordination of standards, take the lead in the formulation of international standards for traditional Chinese medicine, reach international advanced standards for chemical products, keep pace with international standards for biological products, and keep abreast of international standards for pharmaceutical excipients and packaging materials. We will strengthen the development of the technical support system for drug standards, and improve the research capacity for drug standards. We will improve the standard system for medical devices, encourage the formulation of recommended standards in emerging technologies, speed up the simultaneous establishment of projects with international standards, and improve the consistency of domestic and international standards. We will improve the technical support system for cosmetic standards and the working mechanism for making and revising standards.

2. Launch trials of regulatory policies to promote high-quality development. We will deepen the reform of delegating power, delegating power, improving regulation, and improving services. We will carry out trials to select areas with strong industrial strengths, innovate models, or develop distinctive types of products, and explore ways to improve regulatory policies and institutional innovation. We will support the development of pharmaceutical manufacturing clusters in the Beijing-Tianjin-Hebei region, the Guangdong-Hong Kong-Macao Greater Bay Area, the Yangtze River Delta, the Yangtze River Economic Belt, and the Chengdu-Chongqing Twin Cities economic circle, and build innovative platforms and new poles of growth for the pharmaceutical industry. We will support innovation and development in pharmaceuticals, medical devices, and vaccines, work to tackle key and core technologies, and help resolve bottlenecks in industrial innovation and development to raise the overall level of the industry. Encourage pharmaceutical distribution enterprises and modern pharmaceutical logistics enterprises to build pharmaceutical logistics centers, improve the network layout of drug cold storage and the functions of supporting cold chain facilities and equipment, and improve the information management level of the whole process of drug cold chain. Promote pharmaceutical distribution enterprises to be equipped with cold storage in accordance with the requirements of the "Quality Management Standards for Drug Distribution"