Since the launch of the China Drug Regulatory Science Action Plan in April 2019, the State Drug Administration has built 12 regulatory scientific research bases in various ways, relying on well-known domestic universities and scientific research institutions, covering drugs, medical devices, Cosmetics field.

Since the launch of the China Drug Regulatory Science Action Plan in April 2019, the State Drug Administration has built 12 regulatory scientific research bases in various ways, relying on well-known domestic universities and scientific research institutions, covering drugs, medical devices, Cosmetics field. Recently, the State Food and Drug Administration held a report meeting on the work of the drug regulatory scientific research base in Beijing. At the meeting, the heads of 12 regulatory scientific research bases including the Hainan Real World Data Research Institute introduced the work progress of the bases in assisting the development of new regulatory tools, new standards and methods, serving regulatory needs, and promoting the construction of regulatory science disciplines.

Hainan Real World Data Research Institute

Pilot exploration of real-world data applications for medical devices

In November 2020, Hainan Real World Data Research Institute was recognized as a scientific research base for drug and medical device supervision of the State Food and Drug Administration. Relying on the unique policy advantages of the Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the Pilot Zone) and the practical exploration of real-world research, the base strives to promote research on real-world data standards for medicines and medical devices, as well as research on data collection, analysis, and application.

At present, 13 of the 17 real-world data research pilot varieties of drugs and medical devices have carried out substantive research, of which 2 medical devices and 1 drug have been approved to use real-world data to assist clinical evaluation, and 1 drug's domestic data has been declared using real-world data in the pilot area.

Since the preparation of Hainan Key Laboratory for real world data research and evaluation, the leading unit, China evidence-based medicine center of West China Hospital, has participated in and completed the drafting of three normative documents such as the guiding principles of real world data for clinical evaluation of medical devices. The key laboratory has carried out the clinical application of five pilot varieties, providing support for the overall scheme design, quality control and analysis of the real-world data research of six pilot varieties.

In addition, the clinical real-world data research platform of Hainan province built by the Pioneer District Administration Bureau is the first regional real-world data collection and management platform in China, which will provide a model for real-world data collection and management in China.

Scientific research center of traditional Chinese medicine supervision, Chinese Academy of traditional Chinese Medicine

Strive to build a regulatory system in line with the characteristics of traditional Chinese Medicine

After the establishment of the scientific research center for traditional Chinese medicine supervision of the Chinese Academy of traditional Chinese medicine (hereinafter referred to as the center), an expert committee was established to gather domestic authoritative expert resources, carry out scientific research on traditional Chinese medicine supervision, strive to build a supervision system in line with the characteristics of traditional Chinese medicine, and develop new tools, standards and methods.

Supported by the project entrusted by the State Food and drug administration, the center has carried out research on the key information of ancient classic famous prescriptions, the change of production technology of listed traditional Chinese medicine, and the technical requirements for the approval of traditional Chinese medicine decoction pieces.

The center established an expert committee of ancient classics with Wang Yongyan, an academician of the Chinese Academy of engineering, as the chairman and Huang Luqi, an academician of the Chinese Academy of engineering, as the vice chairman, and a special research group headed by researcher Zhang Huamin. Through systematic research and combing research, and after extensive consultation with the expert committee, the center drafted the key information research principles of ancient classic famous prescriptions and the key information table of selected prescriptions. In November 2020, the State Food and Drug Administration and the State Administration of traditional Chinese medicine jointly issued the principles of textual research on the key information of ancient classic famous prescriptions and the table of key information of ancient classic famous prescriptions (7 prescriptions).

In addition, the center also organized 15 traditional Chinese medicine production enterprises to discuss the category, current situation, specific rules, specific cases and existing difficulties of the listed traditional Chinese medicine production process change, and the connection between the change application and the actual production, forming an industry consensus.

Institute of traditional Chinese medicine supervision, Beijing University of traditional Chinese Medicine

It is committed to serving the supervision of traditional Chinese medicine and the industry of traditional Chinese medicine

Since its establishment, the Scientific Research Institute of traditional Chinese medicine supervision of Beijing University of traditional Chinese medicine (hereinafter referred to as the Research Institute) has served the scientific supervision and industry development of traditional Chinese medicine by formulating new tools, new standards and new methods.

Near infrared spectroscopy is widely used in traditional Chinese medicine manufacturers, but there is no unified specification and standard. The group standard of on-line detection of powder mixing uniformity in the production process of traditional Chinese Medicine - near infrared spectroscopy, drafted by the team led by Professor Wu Zhisheng and Professor Qiao Yanjiang of the Research Institute, is of pioneering significance to ensure the quality uniformity and process stability of traditional Chinese medicine preparations and promote the development of the industry.

Relying on the construction of the intelligent customized traceability platform of the special "precision medicinal materials" of the Beijing Municipal Commission of science and technology, Professor Wei Shengli's team explored the establishment of precision medicinal materials test stations throughout the country and realized the dynamic collection of traditional Chinese medicine and traditional Chinese medicine decoction pieces samples in Typical Regions of the country. At the same time, cooperate with other units to establish a detection platform for agricultural residues, heavy metals and near-infrared of traditional Chinese medicine, so as to realize the dynamic monitoring of the quality of traditional Chinese medicine such as licorice and traditional Chinese medicine pieces.

The "drug reassurance" software developed by Professor Zhang Bing's team aims to provide the public with drug information and medication information query services, and provide professional information services of traditional Chinese medicine pharmacovigilance for drug production and R & D enterprises, medical institutions and patients.

The team of researcher Li Jun and researcher song Yuelin carried out the research on "realizing the rapid identification and analysis of chemical components of traditional Chinese medicine", and developed a new direct injection three-dimensional mass spectrometry technology.

Shandong University drug regulatory science research base

Continue to carry out academic research on drugs and medical devices

Since its approval, the scientific research base of drug supervision of Shandong University (hereinafter referred to as the base) has been continuously promoted in academic research and foreign cooperation, and the base construction has been continuously strengthened.

In terms of new tools, Shandong University has established drug ATC classification standards, drug manufacturer standard library, drug basic information standard library, etc. drug data can realize real-time data standardization after cleaning, association and classification, and will mine and analyze drug related data from multiple angles by using model analysis and artificial intelligence technology. In addition, the base has also developed a magnetic levitation artificial heart pump with independent intellectual property rights to realize the independent research and development of ECMO prototype of extracorporeal membrane oxygenation equipment.

In terms of new standards, the base has participated in the drafting, preparation and revision of a series of new standards for medical devices. Such as "guiding principles for technical review of biodegradable magnesium orthopedic implants registration", "guiding principles for technical review of animal experimental research of medical devices Part II: experimental design, implementation and quality assurance", etc.

In terms of new methods, the base established a real-time cell analysis method according to the biocompatibility characteristics of degradable magnesium alloy and degradable PLA complex. Cooperate with the University of Leuven in Belgium to carry out high-throughput screening and evaluation of antiviral drugs in vitro. At present, the base is conducting research on new methods of in vitro skin stimulation of medical devices, using the reconstructed human epidermis model as a substitute for in vivo stimulation test of medical devices.

Institute of drug regulation, Shenyang Pharmaceutical University

Provide decision support for drug regulatory authorities

Institute of drug regulation, Shenyang Pharmaceutical University

Provide decision support for drug regulatory authorities. After more than a year of development and construction, the Institute of drug regulatory Sciences of Shenyang Pharmaceutical University (hereinafter referred to as the Institute) has achieved a series of research results.

Professor Lu Jincai, the academic leader of the Institute, made an important contribution to the drafting of the pharmaceutical data requirements for the communication and exchange meeting in the research process of new traditional Chinese medicine (Trial).

The research project "construction of drug supply chain evaluation model under the background of blockchain technology" undertaken by the Institute aims at the weak links of drug supply chain, optimizes the supply chain by introducing blockchain technology, and provides theoretical support for the healthy and orderly operation of drug supply chain.

"Research on smart drug supervision platform" uses advanced information technology to design each module of the drug supervision platform, realize omni-directional and multi angle supervision, and provide auxiliary decision support for relevant departments of drug supervision.

"RWE's suggestions on supporting the technical guidelines for the review of new drug registration and listing" put forward relevant suggestions on strengthening drug registration and supervision from the aspects of clinical trial design requirements of real-world research and the source of real-world data.

"Pharmaceutical technical requirements for nano injection generic drugs", summarizes the key points of pharmaceutical consistency inspection between Nano injection generic drugs and reference preparations, and provides a reference for formulating the guiding principles for the evaluation of quality and efficacy consistency of nano injection generic drugs suitable for China.

Institute of drug regulation, China Pharmaceutical University

Fully serve the scientific supervision of drugs

Since it was approved, the Institute of pharmaceutical supervision science of China Pharmaceutical University (hereinafter referred to as the Institute) has undertaken a number of projects of relevant national and local departments to fully serve the scientific supervision of drugs.

From late May to the end of June 2019, entrusted by the legal work committee of the Standing Committee of the National People's Congress, the Institute established an expert group to carry out special research on the definition of drugs, study the scope of fake drugs and inferior drugs, and put forward policy suggestions on improving the definition of drugs, the supervision of cell therapy and gene therapy products, and the scope of fake and inferior drugs.

Entrusted by the information center of the State Food and drug administration, based on the relevant concepts of regulatory science, the research institute analyzed the nature, policy needs, current situation and existing problems of the "two products and one machinery" production regulatory data, explored new schemes, and formed a set of "two products and one machinery" production regulatory data fusion analysis tool and analysis mode based on data fusion technology.

At the same time, the research institute cooperated with Beijing Children's hospital to carry out the research on the national major scientific and technological project "the construction of key technology platform for preparation intermediates", which provides an emerging theoretical analysis framework for the whole process supervision of children's drug varieties and creates a new reference path for the development of children's drug use in China.

In addition, based on the scientific concepts and methods of supervision, the Institute comprehensively discusses the discretionary challenges and difficulties in the registration and evaluation of innovative drugs; Study the framework of real-world evidence used in drug review and approval decision-making, and help real-world evidence be more scientifically and effectively used in drug review and approval decision-making in China.

National Academy of medicine and medical device supervision, Peking University

Jointly undertake key research projects in regulatory science

Since its establishment, the National Academy of drug and medical device supervision of Peking University (hereinafter referred to as the Academy) has cooperated with many departments of the State Food and drug administration, undertaken the sub tasks of the first batch of key projects of China's scientific action plan for drug supervision, "methodological research on real-world data for clinical evaluation of medical devices" and "research project on safety monitoring and evaluation methods of post marketing drugs", and actively promoted relevant research.

The Institute participated in the drafting and formulation of guiding principles and standards, such as the guiding principles of real-world data for clinical evaluation of medical devices (Trial), the guiding principles of technical review of registration of mammography X-ray system and the algorithm performance test method of artificial intelligence lung image auxiliary analysis software for medical devices; Carry out the "case study of conditional approval supervision in Europe and America" to provide reference and reference for the conditional approval of drugs and medical devices in China.

The "Research on the application of real-world data / evidence in drug supervision" carried out by the research institute combs the experience of international mainstream countries and regions in the use and supervision of drug real-world data / evidence, investigates the cognition of domestic relevant institutions on drug real-world data / evidence, excavates the supervision problems under the current policy framework, and puts forward operable countermeasures and suggestions that meet the practical requirements of our country.

In addition, the Institute also cooperated with the drug evaluation center of the State Food and drug administration to carry out research on the newly approved bioequivalent drugs in China and put forward the method of testing the mean ratio.

Institute of drug and medical device supervision, Chinese Academy of Medical Sciences

To lay a foundation for standardizing the clinical research of antitumor drugs

Since its establishment, the Institute of drug and medical device supervision of the Chinese Academy of Medical Sciences has been committed to promoting the scientific research of supervision, and has made progress in the research on the progress of clinical trials of antitumor drugs, the formulation of relevant guidelines and specifications, and the construction of clinical trial data standard system.

The team of the drug clinical trial research center of the Cancer Hospital of the Chinese Academy of Medical Sciences published the progress of clinical trials of Chinese cancer drugs in 2019 and the progress of clinical trials of Chinese cancer drugs in 2020, which summarized the development of clinical trials of antitumor drugs in China. At the same time, the research team continued to track the research and development progress of international advanced tumor treatment technologies such as immunotherapy and cell therapy, studied the current international cutting-edge clinical trials of cell and gene therapy, and pointed out the development direction of emerging treatment technologies in the field of tumor.

The Cancer Hospital of the Chinese Academy of Medical Sciences took the lead in cooperating with 7 medical institutions such as Fuwai Hospital of the Chinese Academy of Medical Sciences to carry out the bottom construction of an interdisciplinary and interdisciplinary drug clinical trial platform. At present, the basic data collection norms and standards for clinical trials of major health problems such as tumors, blood diseases and cardiovascular diseases in China have been basically completed.

At the end of 2020, the clinical trial application platform of the Chinese Academy of Medical Sciences developed by the research team completed the test, laying the foundation for cross center clinical research data entry and management and establishing an intelligent and scientific clinical research management mode.

Scientific research base of medical device supervision of Sichuan University

Carry out in-depth research on the theory of medical device supervision

The scientific research base of medical device supervision of Sichuan University (hereinafter referred to as the base) has deeply carried out the scientific research on the supervision theory, policy and innovation of medical devices and bioactive materials, and the Institute has participated in the project and achieved a series of important results.

In participating in the research work of the first batch of key projects of China's scientific action plan for drug supervision, the base actively cooperated with the leading departments of various projects to submit the Research Report on "working process and basic principles of attribute definition of international pharmaceutical machinery combination products", which played a good supporting role in establishing the technical evaluation system of pharmaceutical machinery combination products. The research on the basis and standards of high strength and toughness medical pure titanium and recombinant human collagen has laid a foundation for the formulation of the technical guiding principles of these two new materials in the future. At the same time, the base also participated in the seminar and review meeting on the formulation of the naming guidelines for recombinant collagen biomaterials, which provided support for the introduction of the naming guidelines for recombinant collagen biomaterials; Focus on and improve the systematic construction of the discipline system of real-world data research, preliminarily realize the real-world data research, and support the transformation of pre-market clinical evaluation, review and approval results and institutional innovation.

In addition, the base has also presided over the formulation of national standards related to hydroxyapatite for surgical implants, presided over and participated in the preparation and revision of a number of national and industrial standards related to medical devices, which has promoted the standardization of evaluation methods of medical devices.

Scientific research base of medical device supervision of South China University of Technology

Promote innovation and development in the field of biomaterials

The scientific research base of medical device supervision of South China University of Technology (hereinafter referred to as the base) has carried out a number of work with the goal of building a "world-class scientific research institution of medical device supervision and promoting the development of supervision science".

Participated in the review of 5 guiding principles of bone regeneration technology since the establishment of the base; Edited and participated in 32 national, industrial or group standards, including standard requirements for high dose radiation crosslinked UHMWPE products for surgical implants.

At the same time, through hosting and undertaking the entrusted task, the base has carried out the research, preparation and revision of six new methods, including the characterization method of physical and chemical properties of degradable biomedical metal materials, the quantitative determination method of disposable arterial indwelling needle and the leachable diphenylmethane diisocyanate (MDI) in the kit.

In addition, based on the advantages of South China University of technology in basic research and industrial transformation in the field of biomaterials, in the field of innovative biomaterials, the base strengthens the connection between scientific and technological innovation and industrial development of biomaterials through regulatory scientific research and relevant platform construction, and helps build a policy system and standard system supporting high-quality development in the field of biomaterials; Focus on key technologies and "neck sticking" problems in the field of biomaterials, continue to promote major technological breakthroughs and the transformation and application of achievements, help industrial innovation, improve regulatory efficiency and support scientific regulation.

Cosmetics supervision scientific research base of Beijing University of technology and Industry

Clarify the four research directions of cosmetics supervision Science

Cosmetics supervision scientific research base of Beijing University of technology and Industry

Clarify the four research directions of cosmetics supervision science. The cosmetics supervision science research base of Beijing University of technology and industry (hereinafter referred to as the base) has preliminarily established four research directions: safety and quality control and standardization of cosmetics raw materials with characteristic plant resources, efficacy evaluation of cosmetics, safety risk and standardization of cosmetics packaging materials, key technology research and application demonstration research of the construction of cosmetics big data supervision platform.

The base "Research on the identification of true and false cosmetics based on Raman technology", which can quickly identify true and false cosmetics without experimental material pretreatment. At the same time, the base has established a research method for the consistency between product declaration and product formula. In the case of imperfect cosmetic product standards, the base carries out the research on the consistency between product declaration (label) and actual products, focusing on the qualitative identification of cosmetic product components (verifying whether they are consistent with the label) and whether there are prohibited substances and excessive addition of restricted substances.

In terms of safety and efficacy evaluation of cosmetics and raw materials, the base integrates high-resolution mass spectrometry imaging and lipomics technology to analyze the skin permeability of cosmetics and raw materials in vivo and evaluate the safety and efficacy of cosmetics and raw materials. At the same time, macrogenomics and microbiomics are integrated to study the impact of cosmetics and raw materials on skin micro ecology in vivo, so as to evaluate the safety and efficacy of cosmetics and raw materials.

In addition, the base also actively participates in the overall planning of the construction of cosmetics standard system, and participates in the research and drafting of standards for cosmetics products and packaging materials.

Scientific research base of cosmetics supervision of Jiangnan University

Improve the cosmetics supervision system and evaluation methods

The scientific research base of cosmetics supervision of Jiangnan University (hereinafter referred to as the base) adheres to the development principles of overall planning, highlighting innovation, strengthening management and promoting openness, and carries out research on new tools, standards and methods of cosmetics supervision, so as to provide technical support for cosmetics supervision of the State Food and drug administration.

The base, in cooperation with the cosmetics Supervision Department of the State Food and Drug Administration and the China food and drug testing and Research Institute, has undertaken the five-year plan for the standard of cosmetics raw materials from biological sources and the construction of quality standard system. The plan will be completed before July this year, and then the standard construction will be started.

The research projects of the base mainly focus on the following fields:

First, using new technologies in the fields of molecular probe, new spectral technology, chemical and biosensor, visual detection technology and so on, carry out the research on the detection methods and portable detection equipment for on-site rapid screening of cosmetics prohibited / restricted substances (such as glucocorticoids, sex hormones, antibiotics, heavy metals, etc.).

Second, establish a quality standard system for biological raw materials of cosmetics.

Third, establish the evaluation method of cosmetic efficacy (nourishing, repairing, acne removing and tear free formula).

Fourth, build a basic database of Chinese consumer skin. Cooperate with relevant testing institutions and enterprises to establish a Chinese consumer skin database, and on this basis, provide technical support for the safety assessment of cosmetics and cosmetics raw materials, and provide basic data support for cosmetics enterprises to develop finished products.