Scientific supervision and subject-oriented development of China clinical research / 中国胸心血管外科临床杂志

@#At the end of 2022, the National Medical Products Administration (NMPA), in conjunction with the National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College raised for the first time the important issue of clinical research globally: whether the source of the death time of clinical trials based on the simple follow-up records is credible, and proposed a consensus document on the source of the death time of clinical trials. The results were published in The Lancet Regional Health-Western Pacific, which attracted wide attention and recognition from the international industry. This is the first time that the China consensus on quality standards for clinical research has been ahead of the U.S. Food and Drug Administration and other international colleagues. The NMPA has been leading China in promoting the scientific development of clinical research, so as to constantly establish and improve the scientific regulatory system and ecological system, and promote China's full integration into the global pharmaceutical research and development system. China clinical research institutions and the whole industry are also gradually from standardized development to scientific development, high-quality development process. In this study, we summarized the scientific and subject-oriented development of China clinical research industry in recent years, and continuously strengthened the international competitiveness of China pharmaceutical industry. It is suggested that scientific thinking model should be used to deal with the normative problems in clinical research and promote the development of medical model to scientific model.

Introduction and Reflection on Novel Medical Device Regulatory Science Tool MDDT / 中国医疗器械杂志

In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science. "Medical Device Development Tool" proposed by the U.S. FDA is a novel medical device regulatory science tool, which can help medical device developers to predict and evaluate product performance more efficiently. It is also helpful for regulatory authorities to make regulatory decisions more efficiently. This study introduces the concept, qualification process, role of MDDT in medical device regulation and MDDT examples, and makes some discussion on the device evaluation from the perspective of reliability and validity. MDDT can facilitate the developing of novel medical device.

Overview of the Work Related to Regulatory Scientific Research of Combination Products / 中国医疗器械杂志

Based on the research situation of the regulatory scientific research project of combination products technical evaluation in recent years, this study introduces the relevant research on how to optimize the supervision of combination products, summarizes the research progress and research results of the project, in order to promote the development of related industries.

Discuss on Supervision Mechanism for Online Drug Sales from the Perspective of Regulatory Science / 中国药房

OBJECTIVE：To provide su ggestions for perfecting drug electronic commerce regulatory policy and online drug sale supervision mechanism in China. METHODS ：The evolution of online drug sale policy in China were sorted out. The related regulations of online drug sale supervision mechanism stated in newly revised Drug Administration Law in 2019 and Measures for Online Drug Sale Supervision （Exposure Draft ）in Nov. 2020（hereinafter referred to as New Exposure Draft ）were analyzed on the basis of regulatory science to put forward the opinion. RESULTS & CONCLUSIONS ：Drug e-commerce in China has experienced 4 stages of development ，and is now in a new stage of encouraging innovation ，inclusiveness and prudence. The newly revised Drug Administration Law and New Exposure Draft catch up with the trend of “Internet plus ”development in the new era ，and conditionally liberate the network prescription drug operation ，and build new advantages and new kinetic energy for the development of pharmaceutical business. The new network drug supervision mechanism is an important embodiment of the regulatory department ’s active adaptation to social development ，a specific practice of the innovation of scientific drug regulatory concept，and also provides legal guarantee and policy space for new business forms of innovation drug circulation. However ，the author thinks that the relationship between prescription drug information and drug advertising ，network prescription transmission and authenticity ，legitimacy audit ，as well as the concept definition of sales behavior and service behavior are still questionable. Relevant concepts and terms should be adjusted and redefined. It is suggested that online drug sellers should be defined as “drug e-commerce operators ”or“online drug operators ”. The third party platform of online drug trading is defined as “drug e-commerce platform operator ”or“online drug trading platform operator ”.

Research on Registration System of Medical Device Master Files in China / 中国医疗器械杂志

The registration system of medical device Master Files is established to solve the problem that the outsourcing suppliers are not willing to cooperate with the device applicants in the process of providing medical device application documents. After a brief introduction of Master Files systems established by foreign regulatory agencies, this article focuses on the research of establishing a medical device Master Files registration system in China. The results show that the establishment of Chinese Master Files registration system can both improve the standardization and convenience of outsourcing activities of medical devices, and satisfy the needs of the development of medical device industry and regulatory system. At the same time, the probability of additional risk caused by the implementation of the system is low. Therefore, it is expected that the benefits of the system to promote public health outweigh the potential risks, which demonstrates that establishment of the system has important application values.

Current Progress on Biological Evaluation for Medical Devices / 中国医疗器械杂志

To broadly understand the new direction of biological evaluation for medical devices, we introduced both domestic and international progress of biological evaluation and focused on illustrating the key points on full life-cycle biological evaluation, toxicological risk evaluation, evaluation endpoints and package material evaluation concern as well as how to use the update vision of ISO 10993-1:2018 scientifically and reasonably in order to provide us better services on performing biological evaluation for medical devices.

A dramaturgia dos peritos na ciência regulatória brasileira: o caso da Comissão Técnica Nacional de Biossegurança / The dramaturgy of experts in Brazilian regulatory science: the case of the National Technical Commission for Biosecurity

Resumo A partir de estudo sobre a Comissão Técnica Nacional de Biotecnologia, órgão que concentra as competências de regulação de organismos geneticamente modificados no Brasil, o artigo apresenta uma análise, fundamentada na abordagem interacionista de Goffman, sobre sua atuação. Analisa a comissão como um teatro onde diferentes peritos realizam performances, atuam num palco, com uma plateia, bastidores e conflitos em relação aos papéis representados. Por meio de tais estratégias é possível entender o processo de consolidação e estabilização da comissão como instância decisória sobre organismos geneticamente modificados no Brasil. A estabilização da comissão está associada a uma gestão de palco que remove os conflitos para os bastidores e apresenta as decisões como isentas de interferências políticas ou interesses pessoais.

Abstract This article investigates the Brazilian National Technical Commission on Biosecurity, an agency empowered to regulate genetically modified organisms in the country, and presents an analysis of its performance based on Goffman's interactionist approach. The commission is analyzed as if it were a theater in which different experts perform and act on stage, with an audience, a backstage area, and conflicts related to the roles represented. These strategies make it possible to understand the process of consolidating and stabilizing this commission as a decision-making body on genetically modified organisms in Brazil. The stabilization of the commission is associated with stage management that takes conflicts out of the public view and moves them behind the scenes, presenting decisions as free from political interference or personal interests.

A strategy of constructing the technological system for quality control of Chinese medicine based on process control and management / 中国中药杂志

The current situation, bottleneck problems and severe challenges in quality control technology of Chinese Medicine (CM) are briefly described. It is presented to change the phenomenon related to the post-test as the main means and contempt for process control in drug regulation, reverse the situation of neglecting the development of process control and management technology for pharmaceutical manufacture and reconstruct the technological system for quality control of CM products. The regulation and technology system based on process control and management for controlling CM quality should be established to solve weighty realistic problems of CM industry from the root causes, including backwardness of quality control technology, weakness of quality risk control measures, poor reputation of product quality and so on. By this way, the obstacles from poor controllability of CM product quality could be broken. Concentrating on those difficult problems and weak links in the technical field of CM quality control, it is proposed to build CMC (Chemistry, Manufacturing and Controls) regulation for CM products with Chinese characteristics and promote the regulation international recognition as soon as possible. The CMC technical framework, which is clinical efficacy-oriented, manufacturing manner-centered and process control-focused, was designed. To address the clinical characteristics of traditional Chinese medicine (TCM) and the production feature of CM manufacture, it is suggested to establish quality control engineering for CM manufacturing by integrating pharmaceutical analysis, TCM chemistry, TCM pharmacology, pharmaceutical engineering, control engineering, management engineering and other disciplines. Further, a theoretical model of quality control engineering for CM manufacturing and the methodology of digital pharmaceutical engineering are proposed. A technology pathway for promoting CM standard and realizing the strategic goal of CM internationalization is elaborated.

Development of drug regulatory science in the world / 药物评价研究

Regulatory science of food and drug is a cutting-edge science in recent years.The development of regulatory science and management communities attach importance.The regulatory science is not only research and control the development of pharmaceutical innovation products,but also is useful for regulatory policies,regulatory laws and regulations to build methods,product innovation and technical strategies and various innovative product standards,and R&D assessment of pharmaceutical innovation product safety,effectiveness,quality and performance and scientific regulation are great significance.Especially in the pharmaceutical product development and evaluation and product development,production,circulation supervision has important scientific significance and application value.This paper analyzes the development of international food and drug regulatory science.This article describes the development of the international drug regulatory and regulatory science,and it hopes to benefit researchers and managers from emerging disciplines.

Development of drug regulatory science in the world / 药物评价研究

Regulatory science of food and drug is a cutting-edge science in recent years.The development of regulatory science and management communities attach importance.The regulatory science is not only research and control the development of pharmaceutical innovation products,but also is useful for regulatory policies,regulatory laws and regulations to build methods,product innovation and technical strategies and various innovative product standards,and R&D assessment of pharmaceutical innovation product safety,effectiveness,quality and performance and scientific regulation are great significance.Especially in the pharmaceutical product development and evaluation and product development,production,circulation supervision has important scientific significance and application value.This paper analyzes the development of international food and drug regulatory science.This article describes the development of the international drug regulatory and regulatory science,and it hopes to benefit researchers and managers from emerging disciplines.

Differences on the Regulation between Foods with Health Claims and Ethical Pharmaceuticals from the Viewpoint of Regulatory Science / 日本補完代替医療学会誌

Currently, self-medication, including the use of foods with health claims (FHCs), is promoted as means of increasing our health span. However, the functional substance(s) in FHCs and its actions are diverse, and therefore it is difficult to evaluate their safety and efficacy in clinical trials. In this review article, we describe the definition and the history of regulations regarding FHCs. After discussing their types and features, we explain the differences on regulations between FHCs and ethical pharmaceuticals regarding their safety and efficacy in clinical trials, which are required to provide them with scientific evidence. Finally, we believe that transparent standards regarding the evaluation of FHCs would help increase the use of FHCs and their market value in the future.