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Issuance of the 14th Five-Year Plan for National Drug Safety and High-Quality Development

CCFDIE| Updated: 2021-12-30

Recently, 8 authorities including the National Medical Products Administration (NMPA) jointly issued the 14th Five-Year Plan for National Drug Safety and High-Quality Development (hereinafter referred to as the Plan), which has clarified the guiding ideology for drug safety and promotion of high-quality development during the 14th Five-Year Plan period in China, put forward the overall principles of Five Adherences and main development goals, and formulated 10 main tasks, so as to guarantee drug safety, promote high-quality development of drugs, advance the modernization of drug regulatory system and capacity, and protect and promote public health during the 14th Five-Year Plan period.

The CPC Central Committee and the State Council attach great importance to drug regulation. General Secretary Xi Jinping has made a series of important instructions on drug regulation. The Outline of the People's Republic of China 14th Five-Year Plan for National Economic and Social Development and Long-Range Objectives Through the Year 2035 calls for strict drug regulation, and make clear requirements for relevant practice.

According to the Plan, we shall hold the overall principles of Five Adherences, which is adherence to comprehensive CPC leadership, reform and innovation, scientific regulation, law-based supervision, and social cogovernance, to accelerate China's transformation from a big pharmaceutical manufacturer to a pharmaceutical manufacturing power and better meet the health needs of the people.

The Plan defines the main development goals of the 14th Five-Year Plan period. By the end of the 14th Five-Year Plan period, the overall drug regulatory capacity will approach to the international advanced level, the level of drug safety and supply will continue to improve, and the public will become more satisfied and assured with the quality and safety of drugs. The regulatory environment to support highquality development of the industry will be more optimized, the reform of evaluation and approval will be continuously deepened, a batch of innovative drugs in urgent clinical need will be approved, the marketing of innovative drugs with clinical value will be accelerated, the innovative drugs and medical devices in the world subject to registration application in China will be marketed within the territory of China as soon as possible, 2650 standards of drugs, medical devices and cosmetics will be formulated or revised, and 480 guidelines will be newly formulated; the vaccines regulation will reach the international advanced level, by passing the assessment of national regulatory system for vaccines by the World Health Organization, and we will actively promote that the drug inspection and testing institutions of the provinces where vaccine manufacturers are located have the lot release capacity for main varieties of vaccines manufactured within the jurisdiction; new progress will be made in the inheritance and innovative development of traditional Chinese medicine (TCM), the evaluation evidence system with the combination of TCM theories, experience in human application and clinical trials will be preliminarily established, the safety evaluation methods and standard system meet the TCM characteristics will be gradually explored and established, and the modern regulatory system of TCM will be further improved; great progress will be made in the development of professional talent team, a number of senior evaluators and inspectors with international advanced level as well as academic leaders with excellent professional competence in the field of inspection and testing will be cultured, the professional competence of drug regulators will be significantly improved, and positive results will be achieved in the development of the professional team; the technical support capacity will be significantly enhanced, the full life-cycle pharmacovigilance system will be preliminarily established, positive results will be achieved in the Action Plan for Drug Regulatory Science in China, and the capacities of drug inspection and testing institutions will be significantly improved.

According to the development goals, the Plan proposed 10 main tasks, including implementing the whole-process regulation of drug safety, supporting the industrial upgrade and development, improving the drug safety governance system, continuously deepening the reform of evaluation and approval system, conducting strict vaccines regulation, promoting the inheritance and innovative development of TCM, strengthening the capacity building of technical support, enhancing the building of professional talent team, enhancing the smart regulatory system and capacity building, and enhancing the emergency system and capacity building.

Meanwhile, the Plan proposes 10 key construction projects in the form of special columns, including the action plan for screening drug safety risks, the action plan for improving national drug standards, multisectoral coordination policy toolkit for drug safety governance, acceleration of evaluation and approval system building, improvement of national ADR monitoring system, inspection and testing capacity improvement project, promotion of the building of key laboratory of regulatory science, professional competence improvement project, smart regulation project, and emergency capacity improvement project.

The Plan focuses on the building of professional capacities in evaluation, inspection, testing, monitoring and reevaluation and talent team, and takes the building of drug regulatory system and capacity as the important contents. In addition to "ensuring the safety and safeguarding the bottom line", the Plan proposes the measures for "promoting development and pursuing high line" and promoting high-quality development of drugs.

The Plan calls for strengthening the overall coordination and leadership of drug safety, innovating and improving the support and guarantee mechanism, actively participating in global drug safety governance, and encouraging drug regulators to fulfill their duties and responsibilities. Local governments at all levels shall take the overall responsibility for drug safety within their regions, and all provincial people's governments shall establish a drug safety coordination mechanism to make an overall planning for drug safety and economic and social development.