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Japanese National Center for Child Health and Development HOME Facilities Disclosures To Data Users Basic information on P-MICS DB Information for consideration of P-MICS DB usage Procedures for using the P-MICS DB Expert Review Committee on the P-MICS DB News Contact Us Japanese Pediatric Drug Information Collection Network Development Project Background Pediatric drug development targets a wide range of patients, from newborns to adolescents, and therefore, requires a detailed response to each age group in terms of drug formulation and dosage, as well as difficult safety and efficacy evaluations, and also requires pediatric-specific considerations in planning clinical trials and obtaining consent. These requirements place high barriers against the pharmaceutical companies implementing pediatric drug development on their own initiative. In addition, because of the difficulties in conducting clinical trials for pediatric drugs, sufficient data on the efficacy and safety of the drugs cannot be collected, and as a result, pediatric dosage and administration are often not established or specified in the package inserts. Even under such circumstances, healthcare professionals in the medical field use drugs for which pediatric dosage is not clearly stated in the package inserts by reducing the dosage or changing the formulation as needed, but another challenge is that information on their actual usage has not been sufficiently accumulated. Whereas many new drugs are expected to be developed in the future due to innovations in the medical industry, it is necessary to create an environment in which drugs can be used safely and securely for use in children. Overview The secretariat of the Pediatric Medical Information Collection System (P-MICS) was established at the National Center for Child Health and Development (NCCHD) as part of the Pediatric Drugs Information Collection Network Development Project, which started in FY2012 as a project subsidized by the Ministry of Health, Labor, and Welfare (MHLW). The secretariat has developed the P-MICS using a network of pediatric medical institutions nationwide as a data source for electronic medical records (EMRs) and medical interview systems, and has established an infrastructure to collect, analyze, and evaluate information on adverse events and dosage of pediatric drugs in the P-MICS database (P-MICS DB). Objective The objective of this project is to further improve safety measures for pediatric drugs and to promote the development of pediatric drugs, thereby providing safer and more reliable drugs for children by using the data collected in the P-MICS DB and analyzing and evaluating the actual usage of drugs for children, including dosage and administration methods, as well as information on drug safety, including the occurrence of adverse events. Cooperation Project Committee for Proper Use of Pediatric Drugs In the Pediatric Drug Use Environment Improvement Project, which started in FY2017 as a project commissioned by the MHLW, the Committee for Proper Use of Pediatric Drugs is composed of experts (pediatricians, pharmacists, and other professionals) and regulatory authorities (MHLW, Pharmaceuticals and Medical Devices Agency [PMDA], and other agencies). The committee selects unapproved drugs, off-label drugs, and other drugs for evaluation in pediatric patients, and the secretariat extracts and analyzes information on the drugs targeted for evaluation from the P-MICS DB. Based on the results of the analyses, as well as the literature and overseas information related to the drugs to be evaluated, the committee will clarify the actual usage of unapproved and off-label drugs in pediatric patients, and will consider the possibility of adding such information to the package inserts or filing an application for additional indications, known as "Kouchi-shinsei (public knowledge-based application scheme)", and disclosing the information on the P-MICS website. Facilities Disclosures To Data Users News 2024.04.26 Information on P-MCS DB Usage has been posted. 2024.04.18 We published utilization result announcement. 2024.04.04 Information on P-MCS DB Usage has been posted. 2024.03.22 We published utilization result announcement. 2024.03.21 We published utilization result announcement. 2024.01.26 Information on P-MCS DB Usage has been posted. 2024.01.17 We published utilization result announcement. 2023.12.28 Information on P-MCS DB Usage has been posted. 2023.12.13 Information on the Review Committee for Proper Use of Pediatric Drugs is now available. 2023.11.30 Information on P-MCS DB Usage has been posted. Archives Pediatric Drug Information Collection Network Development Project National Center for Child Health and Development (NCCHD) Secretariat of Pediatric Medical Information Collection System (P-MICS) 2-10-1 Okura,Setagaya-ku,Tokyo &＃12306;157-8535 TEL:+81-3-3416-0181 Privacy Policy © National Center for Child Health and Development All rights reserved.