Drug Evaluation Committee Issues of pharmaceutical documentation for Society 5.0 (data society) and proposals for the use of digital technology
Data Science Subcommittee
June 2024
The Drug Evaluation Committee's Data Science Subcommittee Task Force 2-2 for FY2023 focused on the theme of "How pharmaceutical affairs documents should contribute to innovative drug development and smooth approval review" and identified issues to be addressed in response to various external environmental changes (development of information technologies including AI, data utilization, patient perspective, new study design, etc.). The issues that need to be addressed in order to respond to the diverse changes in the external environment (e.g., development of IT technologies including AI, data utilization, patient perspectives and new study designs) were identified and necessary future measures were discussed.
First, a questionnaire was sent to each company with the aim of identifying issues related to pharmaceutical documentation from the perspective of medical writers (MWs) in anticipation of future changes in the development of pharmaceuticals and medical devices. The results are reported as Appendix 1.
We also organized a session at the 2023 DIA Japan Annual Meeting to discuss the current situation in which communication between regulatory authorities and sponsors/applicants in drug development is changing from traditional paper documents to electronic media, with the aim of maximizing the benefits of various external environmental changes. An image of the changes in pharmaceutical documentation from the present to the future, presented at this session, is reported as Document #2.
Many issues and challenges were extracted from the results of the above questionnaire and discussions at the DIA. Among them, the impact of changes in business models due to generative AI on pharmaceutical documentation and related communication is significant, and it is necessary to expand the scope of its use in a timely manner. On the other hand, we found that misunderstandings and lack of understanding about generative AI have slowed down the speed of consideration of its use in some situations. Based on these findings, we compiled Document (3) with the aim of understanding the current status of generated AI and promoting its appropriate use in pharmaceutical document-related work.
It is hoped that this document will provide an opportunity to think about how pharmaceutical documents should contribute to innovative drug development and smooth approval review toward Society 5.0 (data society), and that it will help to implement further specific guidelines and measures.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Data Science Subcommittee
Task Force 2-2 for FY2023
Tsuyoshi Ishiki (Eli Lilly Japan)
Tadashi Shimada (Chugai Pharmaceutical)
Takana Kamei (Shionogi)
Keiko Tsumori (MSD)
Eri Teraoka (Otsuka Pharmaceutical)
Rika Morita (Pfizer)
Satoru Tsuchiya (Sumitomo Pharma)