Suggestions for Promoting China’s Drug Regulatory Agency to Join Pharmaceutical Inspection Co-operation Scheme-PIC/S

Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme(PIC/S)audit checklist,find out the key improvement items,and revise them pertinently,which will promote the process of China joining PIC/S.Methods The general situation of PIC/S organization and audit checklist were introduced first,and then the accession of several countries that joined the organization was analyzed.Meanwhile,the process of China’s participation in PIC/S was sorted out.After referring to the contents of PIC/S audit checklist,the problems of GMP inspection system in China were studied.Results and Conclusion There are still many problems in GMP inspection in China.Some suggestions are put forward for improvement and change,which can provide reference for the development of drug inspection agencies at all levels in China.

Drug Regulatory Science in EU and Its Enlightenment to China

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.

EU Real-World Evidence Supporting Drug Regulatory Decision and Its Enlightenment to China

Objective To provide references and suggestions for the application of real-world evidence in the decision-making of drug regulation in China.Methods The application of EU real-world evidence in drug regulatory decision support was analyzed through literature research and other methods,and the specific operation of its application was demonstrated by case studies.Results and Conclusion The application of EU real-world evidence in drug regulatory decision-making has achieved certain results and is in a stable development stage.The application of real-world evidence in China’s drug regulation is feasible.The successful application of EU real-world evidence can provide reference for China.

Introduction to Regulatory Affairs and Different Regulatory Bodies for Pharmaceutical Products and Impact of Digitalization on Regulatory Affairs

To ensure the quality and marketability of products, the field of regulatory affairs (RA) serves as an intermediary between regulatory bodies, the industry, and consumers. The primary objective of pharmaceutical registration is centered on the marketing process. The World Health Organization (WHO), Pan American Health Organization (PAHO), World Trade Organization (WTO), International Conference on Harmonization (ICH), and World Intellectual Property Organization (WIPO) play crucial roles in the process. Drug registration and commercialization are overseen by national regulatory authorities initially, following the guidelines of the key organizations. The phenomenon of digital disruption is widespread and has significant effects on several domains of work. This influence has been further intensified by the COVID-19 epidemic, as well as the rapid advancements in the complexity and capabilities of machine learning and artificial intelligence algorithms. The future of this profession is influenced by various trends, including the swift progress in scientific comprehension of diseases, which has resulted in the emergence of novel therapeutic approaches for the treatment and potential eradication of some ailments. The importance of strategic collaborations, alignment, and integration among national regulatory agencies has been heightened by recent global regulatory reforms. This trend is expected to persist. The impact of these elements on regulatory professionals, medication development, and medical practice in the future is a subject of considerable attention. The enhancement of skills and the adoption of a growth mindset are crucial for regulatory affairs professionals to implement the necessary adjustments. This emerging paradigm promotes the cultivation of personal responsibility in individuals’ professional development, fostering adaptability and emphasizing the significance of lifelong learning. Through their actions, these specialists could exert influence on the process of product development, contributing to the improvement of their society.

Introduction to drug regulatory capabilities: a theory and framework

This article explored the definition, dimensions, and building mechanisms of drug regulatory capabilities（DRC） and their relationship with regulatory performance. Based on the theories on organizational capability and their application in public sector, interviews with officers from drug regulatory agencies and analysis of its three determinations, the DRC was defined as the follows： a learned pattern through which the drug regulatory agencies acquire, reconstruct and utilize organizational resources to protect and advance public health. DRC can be divided into different dimensions and structured as the basic capabilities and functional capabilities. This research also introduced three learning mechanisms for DRC construction, which include learning by doing, organizational learning, and exploratory learning. Finally, a qualitative case study of drug application and approval in China was conducted to explore the relationship between regulatory capabilities and performance.

Regulatory evaluation of efficacy and safety of new drugs in China

Accessibility, availability, and rational use of medicines are widely recognized priorities for guaranteeing equity in health care. Commercial pressure can twist health policy if pharmaceutical companies are allowed to promote and impose their products beyond clear public-health interest. National regulatory