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
Data Science Subcommittee
June 2025
Task Force 2-1 of the Drug Evaluation Committee's Data Science Subcommittee in FY2024 examined the creation of guidance for pharmaceutical affairs documentation for medical writers in response to changes in the environment, such as generative AI, under the theme of "How pharmaceutical affairs documentation should contribute to innovative drug development and smooth approval review.
In recent years, pharmaceutical documents are undergoing a major shift from paper to electronic media due to the development of digital technology. In particular, the use of robotic process automation (RPA) and generative AI, the electronic structuring of protocols through ICH M11 and TransCelerate/CDISC, and the platformization of application methods are progressing, and the use of digital technology is essential in the field of pharmaceutical documentation these days. In the field of pharmaceutical documentation, the use of digital technology has become indispensable.
Therefore, this document has been prepared to provide guidelines on how to improve efficiency and quality in the use of digital tools such as generation AI, how skills in handling such tools should be improved, and to provide a reference for preparing pharmaceutical documents in response to the environment of the pharmaceutical industry and social changes.
We hope that this guide will serve as a reference for not only medical writers, but also for pharmaceutical companies deciding to introduce digital tools, as well as for pharmaceutical companies and related companies developing digital tools to meet the needs of digital tools surrounding the pharmaceutical industry.
Japan Pharmaceutical Manufacturers Association
Drug Evaluation Committee Data Science Subcommittee
Task Force 2-1 for 2024
Tadashi SHIMADA (CHUGAI PHARMACEUTICAL CO., LTD.), Tsuyoshi ISHIKI (Eli Lilly Japan Inc.), Rika MORITA (Pfizer R&D, LLC), 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.)