Review Board of Ethical Drug Product Information Brochure
In FY2026, following the October 2023 revision of the Guidelines for the Preparation of Product Information Summaries for Ethical Drugs (hereinafter referred to as the "Guidelines"), we will continue to promote understanding of the Guidelines and promote activities aimed at enhancing appropriate material preparation and material review systems at member companies.
Reinforcement of the inspection system in accordance with the revision of the preparation guideline
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Enhancement of Examination Management
To continue to study the functions of the electronic examination system in order to realize more efficient and effective examinations. In addition, the preliminary meeting system will be enhanced, and review of examination targets will be considered as necessary.
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Reinforcement of the examination system
Reflecting the opinions of external reviewers, such as medical and pharmaceutical experts and the Data Science Subcommittee, we will establish a more advanced review board system and preliminary meeting system from the viewpoint of discussions from the perspective of medical professionals and more accurate communication to medical professionals.
Promotion of understanding of the guidelines
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Clarify the rules of the guidelines.
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Conduct explanatory meetings on the preparation procedures.
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Share case studies and modify some of the contents of the procedure through review meeting reports.
Support member companies' internal auditing and training systems
Since the primary responsibility for materials rests with each member company, the Review Board of Ethical Drug Product Information Brochure will consider measures to support the review by each company.
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Consider expanding the tools for internal training of the guidelines.