Drug Regulatory Science in EU and Its Enlightenment to China

Li Yanying ,Huang Zhe, ,Lian Guiyu＊

(1.School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China 2.Research Institute of Drug Regulatory Science,Shenyang Pharmaceutical University,Shenyang 110016,China)

Abstract Objective To analyze the current situation of research and application of drug regulatory science in EU,and provide suggestions for policy-making of drug regulatory in China.Methods The policy guidelines issued by European Medicines Agency (EMA) and domestic and foreign literature were retrieved to summarize how to carry out drug regulation science in Europe.Results and Conclusion A strategic plan was formulated by the EMA for the implementation of drug regulatory science,and the construction of academic system and discourse system of regulatory science were improved,which played a role in promoting the progress of European drug regulatory science.It is suggested that a phased strategic plan of regulatory science should be established to clarify strategic objectives and main tasks in China as soon as possible.Besides,the construction of discipline system and discourse system should be strengthened to realize the scientific supervision of drugs.

Keywords:EU;EMA;drug regulatory science;enlightenment

1 Introduction

As a new science,the regulatory agencies of various countries have attached great importance to regulatory science since the 1970s[1].From the beginning of the 21st century,the US Food and Drug Administration (FDA) has carried out the research on the application of regulatory science in the drug field.In addition,drug regulatory agencies around the world have also focused on drug regulatory science,which greatly promotes the innovation and development of health science and technology-related industries.At the same time,many countries also realize that mastering and reasonably applying this discipline will have a significant impact on the development of drug regulatory science,because it helps to obtain the international discourse power of pharmaceutical industry[2-3].

Regulatory science is the science of developing new tools,standards or methods to evaluate the safety,effectiveness,quality and performance of regulated products.It has the characteristics of high interdisciplinary and strong application,which has been involved in many research fields and application fields[4].The European Medicines Agency (EMA)defines regulatory science as a series of scientific disciplines that are applied to the quality,safety and efficacy assessment of medicinal products,and it helps make regulatory decisions throughout the life cycle of a medicine.It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools in the “EMA Regulatory Science Strategy to 2025(Draft)”[5].

With the development of the times and the progress of science and technology,EMA is facing two challenges.One is the social problems faced by pharmaceutical industry,such as the rapid increase in the cost of research and development and innovation of drugs,the outflow of a large amount of capital from Europe,the increasing consumption of drugs due to the aging population,the increasingly complex drug supply chain,and the gradual emergence of drug shortage in some regions.The other is the industry challenges brought about by the development of science and technology,such as cell therapy,new clinical trial design,gene diagnosis,real-world evidence,big data,and artificial intelligence[6].Therefore,the EMA is aware that with the continuous changes in the pharmaceutical field and the progress of science and technology,regulatory science should be in line with them simultaneously,so that the EMA can accurately and effectively evaluate the new methods and tools constantly updated in the pharmaceutical field[7].This paper summarizes the development of drug regulatory science in EU,introducing the relevant measures of EU on drug regulatory science to provide new ideas for the development of drug regulatory science in China.

2 The development of EMA in regulatory science

In recent years,the EMA has done a lot of practice in regulatory science,such as constantly soliciting the opinions of relevant stakeholders and establishing the strategic plan of regulatory science,thus better carrying out regulatory science work.The EMA also actively participates in regulatory science academic activities of European and international organizations,and plays a certain role in promoting it[8].

In 2016,the EMA established a monitoring science observatory to timely understand and monitor emerging trends in science and technology and promote the progress of the EMA regulatory science[9].Subsequently,the EMA released the “EMA Regulatory Science Strategy to 2025 (Draft)” in December 2018.After that,the public opinions were widely collected,and the final version was released on March 31,2020.In the draft,the EMA pointed out that the purpose of introducing drug regulatory science is to ensure that regulators can promote the protection of public health in the next few years and provide the best drugs for European citizens.At the same time,the EMA has also clarified the stakeholders of the program.“EMA Regulatory Science Strategy to 2025 (Draft)” mainly introduces five strategic objectives of regulatory science for human medicine:(1) Promoting the integration of science and technology in medicine development;(2) Driving collaborative evidence generation– improving the scientific quality of evaluations;(3) Advancing patient-centered access to medicines in partnership with health-care systems;(4) Addressing the emerging health threats and availability/therapeutic challenges;(5) Enabling and leveraging research and innovation in regulatory science.The EMA also proposes strategic goals for veterinary drugs which include the following.The first is to catalyze the integration of science and technology in medicine development.The second is driving collaborative evidence generation -improving the scientific quality of evaluations.The third is addressing the emerging health threats and availability/therapeutic challenges.Fourth is to enable and leverage research and innovation in regulatory science[5].After each strategic objective,the EMA has developed a set of core recommendations and associated supporting actions,which will guide the work of the European drug administration and national agencies in the coming years.

Finally,the draft emphasizes that with the trend of globalization of pharmacy,it should strengthen international cooperation with other regulatory agencies,which will solve problems,collect resources,help capacity-building and convergence of regulatory tools and standards.

2.1 European practice in organization and personnel training

In recent years,European regulators have carried out in-depth exploration and practice of regulatory science.The EMA has set up organizations to support regulatory decision-making in different fields,such as committee for medical products for human use,committee for medical products for veterinary use,committee for orphan medical products,and pediatric committee.They can approve scientific regulatory decisions on human,veterinary,orphan,herbal and children’s medication[10].At the same time,some unofficial regulatory scientific organizations and research institutions have gradually gained some popularity in Europe.For example,Center for Innovation in Regulatory Science (CIRS) in the UK,which belongs to the Clarivate Analysis Group.It provides a third-party international platform for communication and exchange of regulatory science for the pharmaceutical industry,regulatory agencies,health technology assessment organizations and other health-care stakeholders.Its main task is to maintain leadership in identifying and applying scientific principles to support regulatory and health technology assessment[11].

In addition,the EMA also actively cooperates with some well-known European schools and research institutions.For instance,the EMA and the Massachusetts Institute of Technology set up Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) to cooperate in the research of regulatory science projects as early as 2010.They mainly try to integrate the assessment of patients’ health outcomes and risk preference of interests into regulatory decisions,and adjust regulatory requirements to support the development of safe and effective drugs[12].In addition,Copenhagen Regulatory Science Center in Denmark and WHO Pharmaceutical Policy and Regulatory Science Center of Utrecht University in the Netherlands also carried out relevant cooperation with the EMA,making efforts to cultivate regulatory science talents and carry out academic exchange activities[13].

2.2 The relationship between European regulatory scientific institutions and all sectors of society

In recent years,the EMA has also been in close contact with national regulatory agencies and stakeholders from all walks of life.For example,it has regular discussions with the FDA and Pharmaceuticals and Medical Devices Agency (PMDA) on relevant issues.Since 2018,the multi-stakeholder seminar had been held for two consecutive years to put forward suggestions for determining specific actions of “EMA Regulatory Science Strategy to 2025 (Draft)”[14].Since 2002,CIRS has held hundreds of meetings on regulatory science strategy,stakeholders,assessment tools,and standards.And all the seminar reports have been published on CIRS website[13].

3 Enlightenment to China

3.1 Clarifying the strategic objectives and main tasks of regulatory science

After more than one year of research and consultation,the EMA issued the “Regulatory Science Strategy” in 2020.Although the “China drug regulatory scientific action plan” was launched in April 2019,which determined the first batch of key projects[15],it did not have a systematic and perfect phased regulatory scientific strategic system that could guide the development of drug supervision science in China.Therefore,China should establish a phased strategic plan of supervision science to clarify the strategic objectives and main tasks as soon as possible.It can gradually promote the work of drug supervision in China as planned,which will innovate in the system,tools,standards,and methods of drug review and supervision,thus improving the efficiency of drug review and approval,as well as the effectiveness and level of drug supervision[16-17].

3.2 Speeding up personnel training and actively grasping international discourse power

In recent years,the EMA has held many seminars on regulatory science to contact with international regulatory organizations and universities closely.Therefore,it has achieved a lot in building discipline system,disseminating academic results and values,and enhancing international discourse power.At present,China’s drug regulatory authorities have cooperated with Sichuan University,Shenyang Pharmaceutical University,Beijing University of Chinese Medicine,and other universities to set up regulatory science research institutes,which has taken an important step in personnel training.On November 23,an institute of drug regulatory science was established in Shenyang Pharmaceutical University and it would undertake the corresponding projects.In the future,it will continue to promote the scientific action of drug regulatory in China by taking the advantages of the university.In terms of international exchange and cooperation,China successfully held two global summit of regulatory science[18].Although some achievements have been made,the development of regulatory science in China still lags behind the developed countries.Therefore,we should pay more attention to the cooperation with various scientific research institutions,colleges and universities,experts and scholars to transform the academic achievements into practical application.And then the problems in practical application will be solved in the discipline education to continuously improve the level of discipline construction and discipline system[19-20].In addition,we should actively hold major international regulatory science conferences and cooperate with international organizations to improve discourse power and the level of scientific supervision.

4 Conclusion

The understanding of regulatory science in all countries of the world is becoming better,and the EMA’s work in drug regulatory science has also achieved some results.This year,the final version of“EMA Regulatory Science Strategy to 2025 (Draft)”was released.The EU has made a lot of practice in formulating the regulatory science strategic plan,establishing the academic system and discourse system,which provides reference for the development of drug regulatory science in China.In the future,China should strengthen the contact with drug regulatory agencies around the world to consolidate the academic foundation of drug regulatory science constantly for realizing the scientific supervision of drugs as soon as possible.