Drug Evaluation Committee A Guide for Medical Writers on Preparation of Pharmaceutical Affairs Documents in Response to Changes in the Environment of Generative AI and Other Digital Technologies
June 2025
The Task Force 2-1 of the Data Science Subcommittee of the Drug Evaluation Committee for fiscal year 2024 focused on the theme “The Role of Regulatory Documents in Contributing to Innovative Drug Development and Smooth Approval Review” and considered the development of guidance for medical writers on the preparation of regulatory documents in response to changes in the environment, such as the emergence of generative AI.
In recent years, advances in digital technology have led to a significant shift in regulatory documents from paper to electronic formats.In particular, the use of Robotic Process Automation (RPA) and generative AI, the electronic structuring of protocols based on ICH M11 and TransCelerate/CDISC standards, and the platformization of submission methods are all advancing; as a result, the use of digital technology has become indispensable in today’s regulatory documentation work.
Therefore, this document was created with the aim of providing guidelines on how to improve efficiency and quality through the use of digital tools such as generative AI, how to enhance the skills required to handle them, and how to create regulatory documents that align with the evolving environmental and social changes in the pharmaceutical industry.
We hope this guide will serve as a useful reference regarding the needs for digital tools in the pharmaceutical industry—not only for medical writers, but also for those at pharmaceutical companies who make decisions regarding the adoption of digital tools, as well as for those at pharmaceutical companies and related firms who develop such tools.
Japan Pharmaceutical Manufacturers Association (JPMA)
Drug Evaluation Committee, Data Science Subcommittee
FY2024 Task Force 2-1
Tadashi Shimada (CHUGAI PHARMACEUTICAL CO., LTD.), Tsuyoshi Ishiki (ELI LILLY JAPAN K.K.), Rika Morita (PFIZER JAPAN INC.),Eri Teraoka (OTSUKA PHARMACEUTICAL Co., Ltd.), Takana Kamei (SHIONOGI & CO., LTD.),Saori Ota (GlaxoSmithKline K.K.), Xinru Liu (Astellas Pharma Inc.), Hikaru Nakata (Kowa Company, Ltd.), Kayoko Yamakita (AbbVie GK), Atsuko Kubotani (CHUGAI PHARMACEUTICAL CO., LTD.), Hironori Sakai (Eisai Co., Ltd.)