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

作　　者：Tanzeel Huma Zhou Peng Tanzeel Huma;Zhou Peng(Beijing Yisheng Biotechnology Co., Ltd., Beijing, China)

机构地区：[1]Beijing Yisheng Biotechnology Co., Ltd., Beijing, China

出　　处：《Pharmacology & Pharmacy》2023年第11期463-477,共15页药理与制药（英文）

摘　　要：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 tTo 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 t

关 键 词：Drug Regulatory Authorities Future Trends Centralization of the Regulatory Authorities 

分 类 号：F42[经济管理—产业经济]