2025.01.22Vol.7 No.4 NEWS FDA: [Japanese Translate Version] Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: DRAFT GUIDANCE 7-Jan-2025] Total page-64, upload [REFERENCE] Page
2024.11.09Vol.7 No.1 NEWS MHRA [Policy paper] Impact of AI on the regulation of medical products Published 30 April 2024, and (Japanese Translated Version) Webpage [REFERENCE] Uploaded.
2024.10.31Vol.6 No.16 NEWS November 1st, 2024 marked the third(3rd) anniversary of our incorporation from November 1, 2021. To commemorate this, we renewed our [HiroPharma Webpage] as usual.
2024.08.02Vol.6 No.6 NEWS （Japanese Translation）Korea MFDS: Pharmaceutical Safety Information Regulations, Good Clinical Practice, DSUR Reporting Guidelines: Japanese translation
2024.06.28Vol.6 No.4 NEWS On Monday, July 1, 2024, HiropharmaConsulting celebrated its fifth anniversary since its establishment on July 1, 2019.
2023.10.31Vol.5 No.12 NEWS On Wednesday, November 1, 2023, HiropharmaConsulting Co., Ltd. celebrated its second(2nd ) anniversary since its incorporation.
2023.06.30Vol.5 No.8 NEWS [HiroPharma] As of July 1, 2023, HiropharmaConsulting is celebrating its 4th year in Business, also, on November 1, it will be two full years since the incorporation of the company. Refer to HiroPharma News Vol. 5 No8
2023.01.29Vol.5 No.3 NEWS (Japanese Version) Good Machine Learning Practice(GMLP) for Medical Device Development: Guiding Principles October 2021 (in Joint US FDA/Health Canada/UK MHRA) : Refer from the GAMP® 5/ 2nd Edition Appendix D11 AI/ML
2023.01.15Vol.5 No.1 NEWS We have recently uploaded the Partial Amendments to Postmarketing Adverse Reaction Reporting and Study Adverse Reaction Reporting in Response to E2B (R3) Implementation Guide (2022/2/7 and 2022/6/24) to the Reference Page.
