Research on the Development of Drug Regulatory Science in China

Wang Guanjie,Shao Mingli

(1.School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;2.National Institutes for Food and Drug Control,Beijing 102629,China;3.China Society for Drug Regulation,Beijing 100082,China)

Abstract Objective To study the situation of the development of China’s drug regulatory science and to provide some suggestions for its future development.Methods Based on the origin of regulatory science in China,the methods of literature research and comparison were used to make a detailed analysis of China’s drug regulatory science plan and its implementation effect,the research direction,the number of key laboratories,regulatory science exchange conferences and professional papers published,so as to put forward the development trend of China’s regulatory science.Results and Conclusion According to China’s national conditions,the government should continue to promote the development of the regulatory science system from three aspects: basic theoretical research,discipline construction and action plan.China’s drug regulatory science can not only promote the rapid development of pharmaceutical industry,but also guarantee public health.

Keywords: drug;supervision science;regulatory scientific plan;development trend

As a powerful weapon to safeguard and protect people’s health,the safety of drugs is directly related to the credibility of the government and social stability.In recent years,with the rapid development of genome and cell-based therapies,mobile health products,artificial intelligence and so on,how to safely and rapidly transform them into effective and high-quality therapeutic products is the focus of the pharmaceutical industry and regulatory agencies.With the development of innovative medical products,the US Food and Drug Administration (FDA),the European Medicines Agency (EMA),the World Health Organization (WHO),and the Japanese Pharmaceuticals and Medical Devices Agency(PMDA) have introduced the concept of “regulatory science” in the field of drug supervision,which promotes the development of the pharmaceutical industry and ensures public health.The State Food and Drug Administration (SFDA) also put forward the concept of “scientific supervision” in 2005[1],which is used for drug supervision and management.Starting from the origin of regulatory science,this paper discusses the situation and trend analysis of drug regulatory science in China.

1 The origin of regulatory science in China

The origin of Chinese drug regulatory science can be traced back to 2005 at the earliest.The SFDA summarized and promoted the concept of drug supervision according to the actual situation of drug supervision in China and put forward a new concept of “scientific supervision” for the first time.This concept proposed to grasp these three issues.First,the starting point of scientific supervision is to ensure the safety of public diet and medication.Second,the basic requirement of scientific supervision concept is administration according to laws.Third,the construction of scientific supervision should be guaranteed[2].The concept of “scientific supervision”unifies the concept of food and drug supervision and provides a rudiment for the development of food and drug supervision science.The establishment of Tianjin Binhai Food and Drug Regulatory Science Research Center in 2013 marked the official appearance of regulatory science in China[3].

2 The development of regulatory science in China

2.1 The establishment of the research bases for regulatory science

The establishment of regulatory scientific research base is an important part of the development of regulatory science in China,and it is of great significance to promote its development.From 2013 to 2020,China had established 10 regulatory scientific research bases according to the official websites of National Medical Products Administration,provincial drug administration and the published documents(Table 1).From the way of establishment,China’s regulatory scientific research bases mainly rely on universities or research institutes.From the content analysis of supervision,these bases focus on the fields of medicine,traditional Chinese medicine,medical devices,and cosmetics to carry out research on new technologies,new methods,new tools,new policies,and the training of supervision science professionals.From the regional analysis,the current regulatory agencies are mainly concentrated in the eastern developed areas.In the western region,only Sichuan has established the Institute of Regulatory Science for Medical Devices.With the development of drug regulatory science,more colleges and universities will set up regulatory scientific research bases in the future.

Table 1 Research institutions and direction of regulatory science in China (2013-2020)

(to be continued)

Continued Table 1

2.2 Initiation and implementation of China’s regulatory science plan

The regulatory scientific action plan has played an important role in the innovation and development of the pharmaceutical industry.In 2013,FDA issued the “Strategy and Implementation Plan for Promoting the Regulatory Science of Pharmaceutical Products”[7],which included the regulatory science plan,the progress of regulatory science,the challenges of regulatory science,and the urgent issues to be solved.In 2018,the European Medicines Agency(EMA) released the “EMA 2025 Regulatory Science Strategic Plan”,which redefined the definition of regulatory science and included the integration of regulatory science and technology,the improvement of evaluation quality,the accessibility of drugs and the challenges faced in the future strategic target plan[8].In 2015,Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) also released “Coordination Strategy of International Pharmaceutical Supervision-Regulatory Science Initiative” as the basis of drug supervision[9].

To promote the innovation of regulatory scientific concepts and systems,National Medical Products Administration (NMPA) launched the “China Drug Regulatory Scientific Action Plan” in the fields of drugs,cosmetics and medical devices from 2019 to 2021.The plan mainly focuses on accelerating drug review and approval,new frontier methods of international supervision,etc.It has set up three major tasks,namely,the construction of regulatory scientific research base,the construction of regulatory emergency projects,and drug approval and regulatory innovation.Besides,it started nine frontier research projects,such as technical evaluation and supervision of cell and gene therapy products,and real-world data supporting Chinese medicine[10].The first batch of scientific research projects on drug supervision have achieved certain results.There are 103 new tools,methods,and standards in this project,among which 31 had been released by April 2021.

In June 2021,the NMPA launched the second batch of regulatory scientific actions,which included effective safety evaluation of traditional Chinese medicine,research on evaluation system and methods of stem cells and gene therapy products.Meanwhile,research on new standards,methods and tools for evaluation of diagnosis and treatment products of common diseases and frequently-occurring diseases such as malignant tumors,and evaluation methods of traditional Chinese medicine,drugs for treating rare diseases,innovative and clinically needed medical devices,and some products for new emergent infectious diseases was also carried out.And research on evaluating the safety and effectiveness of nanoinnovative drugs,medical devices,new biomaterials,innovative medical devices,technical guidelines for new cosmetics raw materials,safety monitoring,analysis and early warning methods,and alert technologies and methods of drugs and medical devices was conducted as well[11].

China’s drug regulatory scientific action plan is an important milestone for regulatory scientific research.The launch of the plan focuses on the whole life cycle of drugs,medical devices and cosmetics to carry out research on key projects and urgently needed projects.This plan also develops new tools,new standards and new methods in supervision,which lays a good foundation for the basic research and sustainable development of China’s drug regulatory science.

2.3 The construction of key laboratories for drug regulatory science

Laboratories are the application sites for drug supervision.In order to effectively promote the scientific development of drug supervision,expand the scientific and technological development capability and improve the scientific level of drug supervision,the NMPA issued the “Administrative Measures for Key Laboratories of National Medical Products Administration” at the end of 2019[12].It greatly promoted the scientific development of drug supervision by supporting the construction of national key laboratories.By March 2021,there were 117 national key laboratories,covering many fields such as medicines,blood products,cosmetics,vaccines,packaging materials and accessories,and medical devices,etc.The development of the accreditation of key laboratories provides strong technical support for the research of new tools and methods of supervision.

2.4 Cooperation and exchange of regulatory science

In 2012 and 2018,the “Global Summit of Regulatory Science” was held in China.Experts and scholars from all over the world exchanged views on global regulatory science and technology development issues such as global regulatory needs,challenges and opportunities,emerging technologies and data analysis,and toxicity and safety assessment,which effectively promoted the development of regulatory science in China.The “China Drug Administration Science Conference” organized by China Drug Administration Research Association has been successfully held five times with the following themes such as “drug regulatory reform and innovation”“quality safety and innovative development” “new era,new goal and new journey -drug scientific supervision promoting healthy development” “new system,new requirements and new challenges -drug scientific supervision serving public health”,and “new development stage,concept and pattern -supervision science promoting high-quality development of medical equipment and cosmetics industry”.Based on the actual situation of China’s drug industry,these conferences focused on the latest trends of drug supervision.During the period of 2010-2020,there were dozens of regulatory scientific exchange conferences held in China,covering the fields of medicines,medical devices,and cosmetics in an allround way.

From 2010 to 2020,with the key word of“regulatory science”,93 Chinese papers were published on CNKI,including 7 in 2018,11 in 2019,19 in 2020,and 35 in 2021.From the published literature,it can be seen that the development of regulatory science in the pharmaceutical field has attracted more attention in recent years.

3 Thoughts on the development of drug regulatory science in China

After more than ten years of development,China’s pharmaceutical regulatory scientific system has made some achievements in basic theoretical research,construction of regulatory scientific research base and implementation of regulatory scientific plan,which has played a positive role in promoting the development of China’s pharmaceutical industry.Especially during the COVID-19 pandemic,the emergency review and approval of vaccines for COVID-19 and the rapid development and approval of diagnostic kits are closely related to the development of regulatory science in China.However,the development of China’s drug regulatory science is still in the primary stage.We should pay attention to the combination of theoretical basis and practical application to develop China’s drug regulatory science,using theory to guide practice,and revising theory based on practice,which complement each other and are indispensable.

3.1 Carry out basic theoretical research of regulatory science and establish technical support for drug supervision

China’s drug regulatory science is different from the regulatory science in FDA,and EMA of European Union,but they are also related.China’s regulatory science should first be based on its national conditions,and make clear the question of “working for whom”,so as to discuss “how to manage” and finally achieve“good management”[13].The above work is actually the foundation of China’s drug supervision science and the root of supervision.Only when the root is clear can we avoid detours[14].The particularity of pharmaceutical products is also the basis for further exploration of regulatory science.It is a long process to successfully develop a drug into the market.With the development of China’s economy,people pay more attention to health products,including medicines,medical devices,and biological products.The biggest difference between health products and other commodities is that their effectiveness,safety,quality,and reliability can directly affect human health and even life.Therefore,the research and development,listing,production and delisting of medical and health products are subject to scientific supervision.Therefore,supervision science is the basis for administrative departments to carry out scientific supervision.

3.2 Conduct discipline construction of regulatory science to ensure the sustainable development of regulatory science

From the definition of regulatory science,it is a comprehensive discipline integrating management,application,methods and technology.Many American universities have developed the discipline of regulatory science and other disciplines such as the basis of regulatory science,law,clinical research,and statistics[15].At present,many universities in China have established the platform of regulatory science.But now the disciplines of regulatory science need to be supplemented urgently.

The regulatory science plan should mobilize the resources of the whole society,relying on wellknown domestic universities and scientific research institutions to carry out in-depth research on the basic theory of drug regulatory science,which can promote the discipline construction of regulatory science,and train leading talents in regulatory science.

3.3 Implement the plan of drug regulatory science and promote the development of scientific supervision to keep pace with the times

At present,China has launched a scientific supervision plan and organized its implementation,striving to promote the scientific development of China’s supervision and seize the commanding heights of innovative technologies in the pharmaceutical industry.For example,in order to speed up the drug supervision by building the “big system,big platform and big data” to realize the integration and development of supervision and information technologies such as cloud computing and internet plus,the “smart supervision plan” was put forward by the NMPA,which displays the close combination of scientific supervision and national conditions[16].We should not only pay attention to the basic theory of regulatory science,but also develop with the times.In terms of strategy,we should formulate a scientific plan for supervision and conduct research on it to provide technical support and basis for its development.

Drug regulatory science is a multidisciplinary system involving politics,society,and management.Its core is the innovative practice of new standards,tools and methods for research and development,prediction,evaluation,selection and verification of drug safety and effectiveness.During the COVID-19 pandemic,the Chinese government took strong prevention and control measures,which has achieved very good results.Regulatory science played an important role in the researches and development of special drugs in some emergencies and the rapid approval procedures.At present,the in-depth implementation of China’s drug regulatory science plan has been included in the “14th Five-Year Plan for National Drug Safety and Promotion of High-quality Development”.Therefore,regulatory science will play a greater role in the development of pharmaceutical industry in the future.