Launching an Action Plan for Drug Regulatory Science in China

  • 2019-05-06
The first projects including cell and gene therapy products, drug-device combined products, AI medical devices and research on TCM safety evaluation were approved.

In order to thoroughly implement the “Four Most Stringent” requirements for drugs put forward by General Secretary Xi Jinping, promote the innovation in supervision concepts, systems and mechanisms and accelerate the transition from a big pharmaceutical country to a great pharmaceutical power based on the theme of "innovation, quality, efficiency, system and capacity", NMPA today issued a notice to decide to carry out the research on the regulatory science of drugs, medical devices and cosmetics and launch an action plan of drug regulatory science in China, and determines the first batch of nine key research projects.

It is pointed out in the notice points that China will closely follow the frontiers of international regulation based on China's actual drug regulation and the reform and innovation in drug evaluation and approval system, and formulate a number of regulatory policies, evaluation guidelines for technical specifications, examination, inspection and evaluation techniques, technical standards and others through regulatory tools, standards and methods after three to five years of efforts so as to effectively solve prominent problems that affect and restrict the innovation, quality and efficiency of drug and accelerate the modernization of drug management system and management capacity.

The action plan for regulatory science specifies the following three key tasks:  building three to five drug regulation scientific research bases, launching a number of key projects of regulatory science, and introducing new systems, tools, standards and methods for drug evaluation and regulation.

These key projects of regulatory science will be soon launched by stages and in batches to achieve breakthroughs in key fields. These projects will focus on the cutting-edge and cross products used for cell and gene therapy products, regenerative medicine and drug-device combination etc. Led by competent business divisions and departments, innovative research will be carried out with the support of directly affiliated units and some provincial administrations in combination with universities, research institutes and industrial associations.

The first batch launched according to the action plan has nine projects, including the research on technical evaluation and regulatory system of cell and gene therapy products, the research on the safety evaluation and quality control of nano drugs, the research on safety evaluation for traditional Chinese medicine oriented to clinical TCM, the research on safety monitoring and evaluation method of post-marketing drugs, the research on technical evaluation for drug-device combined products, the research on safety and effectiveness of AI medical devices, the research on regulatory science of new materials for medical devices, the research on methodology for real data for clinical evaluation of medical devices, and the research on methods for cosmetics safety evaluation.

The drug regulation scientific research bases will focus on drug life cycle to research into key projects of regulatory science, develop a series of new tools, standards and methods, and strengthen China's foundation of drug regulatory science so as to promote the sustainable development of drug regulatory science with the support of famous colleges, universities and research institutes at home and abroad. Besides, these bases will carry out in-depth research on the basic theories of drug regulatory science, promote the discipline construction of regulatory science and cultivate leading talents in regulatory science.

Source: National Medical Products Administration