Recently, in order to fully implement the requirements of the “Implementation Opinions of the General Office of the State Council on Comprehensively Strengthening the Capacity Building of Drug Supervision” (Guobanfa [2021] No. 16), the State Food and Drug Administration issued the second batch of the “China Drug Regulatory Scientific Action Plan” project”. There are 10 key projects in the second batch, and 7 key projects related to medical devices.

1. Real-world data supports research on evaluation methods of traditional Chinese medicine, rare disease treatment drugs, innovation and clinically urgently needed medical devices

For the purpose of encouraging innovation in medicines and medical devices, improving the quality and efficiency of clinical evaluation, and expanding sources of clinical evidence, it focuses on the real-world evidence technology evaluation requirements applied to the review of traditional Chinese medicines and rare disease treatment drugs, and the real world applied to the review of medical devices Data standards, data acquisition systems, and regulatory usability evaluation methods, etc., research real-world data collection, quality evaluation, processing and analysis standards that meet China’s national conditions, and form new evaluation tools, new standards, and new methods for real-world evidence to support regulatory decision-making.

2. Research on the diagnosis and treatment of emerging infectious diseases

Focusing on the urgent clinical needs of epidemic prevention and anti-epidemic, for the construction of the etiology and prevention technology system of emerging infectious diseases, the development and evaluation of diagnostic and therapeutic products, etc., the performance evaluation of diagnostic reagents for emerging infectious diseases, the development and development of treatment and preventive drugs Research on the evaluation system to form relevant technical norms guidelines and evaluation technical standards.

3. Research on the safety, effectiveness and quality control evaluation of nano innovative drugs and medical devices

On the basis of preliminary research, focus on the application of nanotechnology in cutting-edge and cross-cutting products such as innovative drugs and medical devices, and carry out in-depth development of the safety, effectiveness and quality control and evaluation technology of nano-pharmaceuticals, and the quality control of nano-medical device products And evaluation technology, etc., to form guidelines and related standards for evaluation technical specifications.

4. Evaluation of innovative medical equipment based on remote transmission, flexible electronic technology and medical robots

Focus on cutting-edge and cross-cutting products such as new high-end medical equipment, carry out the evaluation of the safety and effectiveness of medical device products based on remote/wireless transmission technology, and the safety of a new generation of wearable and active implantable medical device products based on flexible electronic technology Effectiveness evaluation, medical robot inspection and evaluation technology research, formation of inspection and evaluation technical guidelines and standard specifications, etc.

5. Research on the safety and effectiveness evaluation of new biomaterials

In response to the regulatory and evaluation issues in the use of new biomaterials for medical devices, we will focus on new materials such as bio 3D printing, tissue engineering medical device products, innovative medical biomaterials, recombinant collagen, cartilage regeneration materials, orthopedic oral antibacterial materials, etc. Performance evaluation and safety effectiveness evaluation research, forming relevant guiding principles and technical review system. Carry out research on alternative methods of artificial skin and cornea, establish skin models based on Chinese human-derived cells and evaluation criteria for whitening efficacy based on melanin-containing skin models, etc.

6. Research on new tools, new standards and new methods for evaluation of common diseases and frequently-occurring diagnosis and treatment products such as malignant tumors

For common diseases and frequently-occurring diseases such as malignant tumors, carry out early diagnosis and clinical evaluation of screening products, model-guided drug review technology and standards, patient-centered drug clinical trial evaluation system, continuous manufacturing technology implementation and technical requirements, and accompanying Research on new tools, new standards and new methods such as diagnostic in vitro diagnostic reagent regulatory standards and methods, and form relevant technical guidelines and review paths for clinical evaluation and drug development.

7. Research on warning technologies and methods for drugs and medical devices

Focusing on key pharmacovigilance technologies and tools, active and high-risk implantable passive medical device safety monitoring and evaluation technologies, and key technologies for post-marketing TCM adverse reaction monitoring, strengthen signal identification and early warning, verification and risk assessment, and automated reporting Research on key technologies such as quality assessment. Establish a spontaneous report and active monitoring system for drug and medical equipment alert, and continue to improve alert intelligence and modern monitoring and evaluation capabilities.

In principle, the execution cycle of this batch of key projects is two years. All projects are led by relevant departments and bureaus of the State Food and Drug Administration, and are implemented by relevant directly affiliated units. In principle, the cooperative units rely on the State Food and Drug Administration to supervise scientific research bases and key laboratories. The State Food and Drug Administration requires all leading units and implementing units to research and formulate project implementation plans, clarify research plans, refine research objectives and tasks, implement cooperative units, and accelerate innovation in accordance with the principles of focusing on the frontiers, highlighting key points, strengthening actual results, and steadily advancing Regulatory tools, standards, and methods will further enhance drug regulatory capabilities and levels, accelerate the launch of innovative products, and better meet public health needs.

The China Pharmaceutical Regulatory Scientific Action Plan was launched in April 2019, and the first batch of 9 key research projects were simultaneously identified . After two years of hard work, the first batch of key projects has studied and formulated 103 new regulatory tools, new methods, and new standards , of which 31 have been released.

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