2025.07.01Vol.8 No.1 NEWS This time, we are pleased to announce the complete renewal and reopening of the [HiroPharma Webpage] to commemorate the 6th anniversary of HiroPharma Consulting (established on July 1, 2019).
2025.05.17Vol.7 No.15 FDA Uploaded (Japanese Translate Version) FDA [Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. Draft Guidance for Industry and Other Interested Parties]
2025.05.14Vol.7 No.14 FDA FDA : Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. Draft Guidance for Industry and Other Interested Parties
2025.05.07Vol.7 No.13 ISPE [ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) [Japanese Translation] Published: April 2025 Pages: 410]
2025.04.23Vol.7 No.12 NEWS Indian Pharmaceutical Industry: Creating Global Impact & [CDSCO: Central Drugs Standard Control Organization] / [Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products Version: 2.0]
2025.04.04Vol.7 No.11 NEWS [METI] Announced January 15, 2024: [ISO/IEC 42001 and ISO/IEC 42006] the Ministry of Economy, Trade and Industry News Release on AI.
2025.04.02Vol.7 No.10 NEWS Summary of the report "AAAI 2025 PRESIDENTIAL PANEL ON THE FUTURE OF AI RESEARCH" published by AAAI(Association for the Advancement of Artificial Intelligence) in March 2025.
2025.03.08Vol.7 No.9 NEWS (Japanese Translate Version) EMA: European Medicines Agency: [Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle]. Uploaded HiroPharma [REFERENCE 2025/3/8].
2025.02.27Vol.7 No.8 FDA FDA: [Japanese Translate Version] DHAC Executive Summary - Total Product Lifecycle Considerations for GenAl Devices" --> uploaded [REFERENCE] 2025/2/27
2025.02.17Vol.7 No.7 NEWS How to Validate GxP Application with AI Features for Life Sciences Companies & AI Regulation, Guideline Reference List.
2025.02.13Vol.7 No.6 NEWS AI Business Guideline (Version 1.01) November 22, 2024 (2024/11/22) [Main and Attachment] The Ministry of Internal Affairs and Communications/the Ministry of Economy, Trade and Industry (Japanese/English).
2025.02.10Vol.7 No.5 NEWS Guidance on "Validation Service at the time of (and after) introduction of AI GVP (GxP)" for Pharmaceutical and Medical Device Manufacturers planning to implement and update GVP (GxP) Systems with AI functions.
