Planning of the Pediatric Drug Development Program during Development of Drugs for Adults, PSB/PED Notification No. 0112-3 issued by Director of Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare on January 12, 2024 https://www.pmda.go.jp/files/000268525.pdf Partial Revision of “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults“, PSB/PED Notification No. 0329-1 issued by Director of Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare on March 29, 2024 https://www.pmda.go.jp/files/000268523.pdf Q & A for “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults”, Administrative Notice issued by Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare on March 29, 2024 https://www.pmda.go.jp/files/000268524.pdf Partial Revision of “Designation of Orphan Drugs etc.” PSB/PED Notification No. 0116-1 and PSB/MDED Notification No. 0116-1 issued by Director of Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, and Director of Medical Device Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare on January 16, 2024 https://www.pmda.go.jp/files/000268408.pdf Basic principles for conducting phase 1 studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan, PSB/PED Notification No. 1225-2, by Director, Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare, on December 25, 2023 https://www.pmda.go.jp/files/000266727.pdf Pediatric Drugs WG Orphan Drugs WG Multi-Regional Clinical WG Trials Guidelines for Continuous Manufacturing of Drug Substances and Drug Products, PSEHB/PED Notification No. 0531-1, by the Director, Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare on May 31, 2023 https://www.pmda.go.jp/files/000249411.pdf Innovative Manufacturing Technology WG Revision of "Points to consider for application for approval of drugs to be administered based on specific biomarkers that were developed by clinical trials conducted by a sponsor-investigator in patients with rare cancer", PSB/PED Notification No. 0319-1 and PSB/MDED Notification No. 0319-1 issued by Director of Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare, and Director of Medical Device Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare on March 19, 2024 https://www.pmda.go.jp/files/000267507.pdf(in Japanese) Companion Diagnostics WG ( https://www.pmda.go.jp/english/rs-sb-std/rs/0015.html) Table 2 Main Guidelines Issued after Cross-Sectional Discussions (FY 2023) 11 In order to address cross-sectoral issues in reviews and post-marketing safety measures, PMDA has established working groups (WGs) consisting of multiple divisions to discuss each issue, and has been working for the publication of our perspective and development of guidelines, etc. for the solutions, taking international harmonization into consideration. Table 2 below provides the main guidelines, etc. issued in FY 2023 that were supported by each working group. The basic concept was clarified on the handling of development plans for pediatric drug, which should be developed during the drug development period for adults Clarification of points on specific handling in the development plan for pediatric drugs Q & A for making development plans for pediatric drugs, which should be developed during the drug development period for adults Revision of designation criteria for the number of subjects, medical needs, possibility of development, etc. for designation of orphan drugs, etc. Clarification of basic principles for conducting phase 1 studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in cases where early clinical development is preceding outside Japan Clarification of points to consider for the development, implementation, operation, and life cycle management of continuous production (cooperation in activities as ICH Q13) Revision of points on the use of in vitro diagnostics or medical devices approved for other indications in tests for subject enrollment in investigator-initiated clinical trials in patients with rare cancers Related working group Guidelines, etc. involved Overview RS Projects Across Multi-Offices in PMDA
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