Drug Evaluation Committee Issues of pharmaceutical documentation for Society 5.0 (data society) and proposals for the use of digital technology
June 2024
The Task Force 2-2 of the Data Science Subcommittee of the Drug Evaluation Committee for fiscal year 2023 focused on the theme “The Role of Regulatory Documentation in Contributing to Innovative Drug Development and Smooth Approval Review.” The task force identified challenges related to a wide range of changes in the external environment (including advancements in IT technologies such as generative AI, data utilization,the patient perspective, and new trial designs), and discussed necessary future measures.
First, with the aim of identifying challenges related to regulatory documents from the perspective of medical writers (MWs) in anticipation of future changes in pharmaceutical and medical device development, a survey was conducted among various companies. The results are reported in Document 1.
In addition, we organized a session at the 2023 DIA Japan Annual Meeting. Against the backdrop of the shift in communication between regulatory authorities and sponsors/applicants in drug development from traditional paper documents to electronic media, we held a discussion aimed at maximizing the benefits of various changes in the external environment.The vision for the evolution of regulatory documents from the present to the future, presented during this session, is reported in Document 2.
While the results of the above survey and the discussions at DIA revealed many issues and challenges, we concluded that, above all, the impact of business model changes driven by generative AI on regulatory document preparation and related communications is significant, and that we need to expand its scope of use in a timely manner.On the other hand, we found that misunderstandings and a lack of understanding regarding generative AI are causing the pace of consideration for its adoption to be slow. Based on these findings, we compiled Document 3 with the aim of understanding the current state of generative AI and promoting its appropriate use in regulatory documentation-related tasks.
We hope this deliverable will serve as a catalyst for considering the ideal form of regulatory documents that contribute to innovative drug development and smooth approval reviews in the context of Society 5.0 (the data society), and that it will help facilitate the implementation of further concrete guidelines and measures.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee, Data Science Subcommittee
FY2023 Task Force 2-2
Tsuyoshi Ishiki (Eli Lilly Japan)
Tadashi Shimada (Chugai Pharmaceutical)
Takana Kamei(Shionogi & Co., Ltd.)
Keiko Tsumori (MSD)
Eri Teraoka (Otsuka Pharmaceutical)
Rika Morita (Pfizer)
Satoru Tsuchiya (Sumitomo Pharma)